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Acknowledgements | The authors wish to acknowledge the support and active input from the Scientific Coordinating Committee (SCC) and from the Research Governance and Support Services, MRC Unit The Gambia at LSHTM. We would like to thank the management and staff of the Ministry of Health of The Gambia and of Kanifing General Hospital for their support in conducting the study at the hospital premises. The authors thank the staff of the MRC Unit The Gambia at LSHTM and, in particular: Fatou Y. Manneh for data collection activities, Penda John and Fatou Jaiteh for valuable input in designing the protocol and focus group discussion guide. Finally, we are grateful to the many study participants who have been so willing to contribute to this study. | PMC10207755 | ||
Authors’ contributions | SKV and FK conceived and designed the study. SKV, OJ, MB, AP, and MJ oversaw and conducted the research in The Gambia. SP oversaw data analysis, while PHJ contributed to the data management and qualitative analysis. SP and SU drafted the first version of the manuscript. All authors critically reviewed and approved the final version of the manuscript. All authors agreed to be accountable for all aspects of the work. | PMC10207755 | ||
Funding | Funding for the PRIMORDIAL study is from Medical Research Council, UK (MR/R020345/1) the Global Challenges Research fund, University of Oxford, UK (0006138), and Newton Fund (BT/IN/DBT-MRC/DIFD/JM/12/2018–19). | PMC10207755 | ||
Availability of data and materials | The datasets generated and/or analysed during the current study are not publicly available due to reasons of sensitivity but are available from the corresponding author on reasonable request. | PMC10207755 | ||
Declarations | PMC10207755 | |||
Ethics approval and consent to participate | The study was approved by The Gambia Government/MRCG Joint ethics committee (SCC 1620). Written informed consent was obtained by means of participant dated signature and dated signature of the person who administered the ICF. In cases of illiterate participants, her left thumb impression was obtained and this procedure to take the consent of illiterate people was approved by The Gambia Government/MRCG Joint ethics committee (SCC 1620). All methods were performed in accordance with the Declaration of Helsinki’s guidelines. | PMC10207755 | ||
Consent for publication | Not applicable. | PMC10207755 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10207755 | ||
References | PMC10207755 | |||
Background | cubital tunnel syndrome | CUBITAL TUNNEL SYNDROME | This study was designed to investigate whether intraoperative electrical nerve stimulation has effects on the short-term recovery of cubital tunnel syndrome patients after ulnar nerve release. | PMC10069011 |
Methods | cubital tunnel syndrome | CUBITAL TUNNEL SYNDROME | Patients diagnosed as cubital tunnel syndrome were selected. At the same time, they received conventional surgery treatment. The patients were divided by a randomized digits table into two groups. The control group underwent conventional surgery, and the electrical stimulation (ES) group underwent intraoperative electrical stimulation. All the patients were tested for sensory and motor functions, grip strength, key pinch strength, motor conductivity velocity (MCV), and maximum compound muscle action potential (CMAP) before operation and 1 month and 6 months after operation. | PMC10069011 |
Results | In patients treated with intraoperative ES, the sensory and motor functions and the strength of muscle were significantly improved after 1-month and 6-month follow-up than the control group. After the follow-up, the patients in the ES group had significantly higher grip strength and key pinch strength than the control group. After the follow-up, the patients in the ES group had significantly higher MCV and CMAP than the control group. | PMC10069011 | ||
Conclusion | cubital tunnel syndrome | CUBITAL TUNNEL SYNDROME | Intraoperative electrical stimulation of nerve muscle can significantly promote the short-term recovery of nerve and muscle functions after the surgery in cubital tunnel syndrome patients. | PMC10069011 |
Keywords | PMC10069011 | |||
Introduction | Cubital tunnel syndrome, neuropathy | CUBITAL TUNNEL SYNDROME, NEUROPATHY | Cubital tunnel syndrome is a common neuropathy [Electrical stimulation is attracting increasing attention due to its promising role in promoting neuromuscular movement and facilitating peripheral nerve regeneration [ | PMC10069011 |
Methods | PMC10069011 | |||
Participants | Tinel's nerve percussion, paresthesia, numbness, elbow injury, pain, cubital tunnel syndrome, Tinel, clawhand deformity | MUSCLE WEAKNESS, MUSCLE ATROPHY, PARESTHESIA, DIABETES MELLITUS, VASCULAR DISEASE, SECONDARY, CUBITAL TUNNEL SYNDROME, PERIPHERAL NEUROPATHY | Participants in this randomized clinical trial were cubital tunnel syndrome patients who required surgical treatment after ineffective conservative treatment at our hospital from June 2018 to June 2021. The patients were divided by a randomized digits table into two groups. The control group underwent conventional surgery, and the electrical stimulation (ES) group underwent intraoperative electrical stimulation. The study was approved by the ethics committee of the Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine, and all the participants signed informed written consent.The patients were diagnosed with cubital tunnel syndrome through physical examination, electromyography, and ultrasonography, and the conservative treatment was ineffective. The preoperative physical examination met all the criteria: 1. numbness of ulnar nerve innervation region; 2. dorsal interosseous muscle atrophy; 3. clinical Tinel's sign or positive for the elbow flexion test; 4. clawhand deformity; 5. fractioned measurement of the nerve conduction velocity with stimulation of the ulnar nerve at the wrist, distally and proximally to the cubital tunnel (with a distance of more than 10 cm).The inclusion criteria were: 1. diagnosed with cubital tunnel syndrome; 2. ineffective conservative treatment; 3. having paresthesia, numbness, muscle weakness, or pain in ulnar nerve distribution; 4. having positive electromyography and Tinel's nerve percussion test results.The exclusion criteria were: 1. having previous elbow injury or other secondary associated pathologies; 2. having previous peripheral neuropathy; 3. having metallic implants or non-magnetic resonance imaging (MRI) safe active implants; 4. having diabetes mellitus, vascular disease, or other polyneuropathies.Of the 207 patients included in the eligibility assess, 25 were excluded. A total of 182 patients were randomized into the two groups. Participants were followed up for 6 months. Finally, 87 cases in the control group and 89 cases in the ES group were analyzed. Study flow diagram was shown in Fig. Study flow diagram | PMC10069011 |
Surgical procedures | swelling | All surgeries were performed by the same surgical team and under general anesthesia. The ulnar nerve was released at all common sites of compression around the elbow. An in-situ decompression was performed in the majority of cases. Intraoperative electrophysiological monitoring was performed before and after the decompression. The compound muscle action potentials (CMAP) amplitudes of the abductor digiti minimi (ADM) muscle and the motor nerve conduction velocity (MNCV) in the ulnar nerve were recorded. After the decompression, patients in the ES group received electrical stimulation. In this study, alternative high- and low-frequency electrical stimulation was used (100 mA, 2 Hz/15 Hz, 15 min). After the decompression, patients in the ES group received electrical stimulation on the most severely compressed site. In this study, alternative high- and low-frequency electrical stimulation was used (100 mA, 2 Hz/15 Hz, 15 min). Electrical stimulation was performed by Grass SD9 stimulator (Grass Technologies, Warwick, Rhode Island). The proximal wire electrode was connected to the cathode and the distal to the anode.The conservative treatments included oral analgesics, nonsteroidal anti-inflammatory drugs, and neurotrophic drugs; in addition, the patient has a history of treatment related to acupoint application of traditional Chinese medicine for promoting blood circulation and reducing swelling. | PMC10069011 | |
Outcome assessment | Fasciculations, pain | CONTRACTION, FLICKER | Motor and sensory functions were evaluated according to the British Medical Research Council (BMRC) scale. Excellent: Complete recovery of muscle strength on the affected side and complete recovery of superficial pain and tactile sensation. Good: Incomplete recovery of muscle strength on the affected side and incomplete recovery of superficial pain and tactile sensation. Muscle contraction can still move joint against week resistance. Fair: Incomplete recovery of muscle strength on the affected side. Partial recovery of superficial pain and tactile sensation. Muscle strength is further reduced. Poor: No recovery of muscle strength on the affected side and superficial pain and tactile sensation.The strength of muscle was assessed by the Lovett scale. V: Muscle contracts normally against full resistance. IV: Muscle strength is reduced but muscle contraction can still move joint against resistance. III: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. II: Muscle can move only if the resistance of gravity is removed. I: Fasciculations are observed in the muscle or only a trace or flicker of movement is seen or felt in the muscle.Key pinch strength was evaluated by pinch gauge (B&L Engineering, Santa Ana, California). Grip strength was evaluated by Jamar dynamometer (Sammons Preston Rolyan, Bolingbrook, Illinois). | PMC10069011 |
Electromyography | Electromyography examination was performed by a standard EMG system (Nicolet Synergy, Natus Medical Incorporated, San Carlos, USA) through the most widely used methods with good reliability [ | PMC10069011 | ||
Statistical analysis | SPSS 17.0 software (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. Values were shown as n (percentage, %) or mean ± SD. The differences between each group were derived from Mann–Whitney test or Two-way ANOVA followed by Tukey's multiple comparisons test. Fisher’ s exact test or Chi-square test was used for assessing distribution of observations between two groups. | PMC10069011 | ||
Results | cubital tunnel syndrome | CUBITAL TUNNEL SYNDROME | Table Baseline characteristics of cubital tunnel syndrome patients treated with intraoperative electrical stimulation (ES) and controlValues were shown as The sensory and motor functions of cubital tunnel syndrome patients after 1-month and 6-month follow-up were evaluated by the BMRC scale. As shown in Table Comparison of sensory and motor functions of cubital tunnel syndrome patients treated with intraoperative electrical stimulation (ES) and controlValues were expressed as The strength of muscle was assessed by the Lovett scale. As shown in Table Comparison of Lovett muscle grading of cubital tunnel syndrome patients treated with intraoperative electrical stimulation (ES) and controlValues were expressed as The key pinch strength and grip strength of the cubital tunnel syndrome patients were also evaluated. Before the surgery, both key pinch strength and grip strength showed no significant differences between the two groups (Fig. Comparisons of Grip strength (Before the surgery, both MCV and CMAP showed no significant differences (Fig. Comparisons of motor conductivity velocity (MCV) ( | PMC10069011 |
Discussion | trauma, peripheral nerve injuries, nerve injury, cubital tunnel syndrome | CARPAL TUNNEL SYNDROME, CUBITAL TUNNEL SYNDROME | A large number of researchers have carried out studies related to the repair function of electrical stimulation in nerve injury, proving effectiveness and reliability from a practical point of view [Despite the potential of damaged peripheral nerves to regenerate axons, functional recovery after severe nerve injury in humans remains poor [In this study, we applied an electromyograph to intervene in the postoperative recovery of patients with cubital tunnel syndrome in the form of electrical stimulation, and two tests were applied to assess the patient's neurological recovery, i.e., electromyographic indices, and sensory and motor functions to assess the patient's clinical recovery. The electromyograph allows the adjustment of stimulation parameters and treatment time, as well as the postoperative assessment of all electrophysiological aspects of the muscle, thus providing better objectivity.In this study, sensory and motor functions were evaluated at 1 and 6 months of postoperative follow-up. The ES group showed a significantly faster motor and sensory function recovery compared to the control group. The performance of intraoperative electrical stimulation enhanced motor and sensory function recovery in cubital tunnel syndrome patients.The Lovett muscle strength grading was used to evaluate the finger muscle strength of the patients at 1 and 6 months postoperative follow-up. The comparison showed that the recovery of muscle strength in the ES group was also superior to the control group. The performance of intraoperative electrical stimulation enhanced the recovery of muscle strength after surgery.The key pinch strength and grip strength were compared between the control group and the ES group before surgery and at the postoperative follow-up of 1 and 6 months. There was no significant difference between the two groups before surgery, but the grip strength and key pinch strength recovered faster after surgery in the ES group.The CMAP and the MCV of the ulnar nerve were compared at 1 and 6 months of postoperative follow-up. The MCV and CMAP were not significantly different between the two groups before surgery, but the postoperative recovery was significantly better in the ES group than in the control group.Due to the small sample size of this experiment and the fact that only cubital tunnel syndrome after ineffective conservative treatment was selected as a therapeutic target for nerve injury, while other peripheral nerve injuries (e.g., peripheral nerve dissection due to upper limb trauma, carpal tunnel syndrome due to long-term entrapment) have not been further studied, we will next expand the sample size and further investigate the mechanism of electrical stimulation for nerve recovery. | PMC10069011 |
Authors’ contribution | XZ was involved in conceptualization, data curation, methodology, writing—original draft preparation, investigation, methodology, writing—reviewing and editing. XX helped in data curation, validation, writing—original draft preparation. PW contributed to data curation, writing—original draft preparation. WC was involved in data curation, writing—original draft preparation. YH helped in data curation, writing—original draft preparation. JZ contributed to conceptualization, writing—original draft preparation, supervision, writing—reviewing and editing. All authors read and approved the final manuscript. | PMC10069011 | ||
Funding | None. | PMC10069011 | ||
Availability of data and materials | The data that support the findings of this study are available from the corresponding author, Lei Chen, upon reasonable request. | PMC10069011 | ||
Declarations | PMC10069011 | |||
Ethical approval and consent to participate | The study was approved by the ethics committee of the Hebei Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine, and all the participants signed informed written consent. | PMC10069011 | ||
Consent for publication | Current study is available from the corresponding author on reasonable request. | PMC10069011 | ||
Competing interests | The authors declare no competing interests. | PMC10069011 | ||
References | PMC10069011 | |||
Subject terms | arrhythmia, PV occlusion | RECURRENCE, ATRIAL FIBRILLATION (AF), ARRHYTHMIA | To evaluate the feasibility of cryoballoon (CB) ablation of atrial fibrillation (AF) under the guidance of a new three-dimensional (3D) mapping system KODEX-EPD. 40 patients scheduled for CB ablation of AF in the first affiliated Hospital of Xinjiang Medical University from August 2021 to July 2022 were randomly divided into two groups: KODEX-EPD 3D mapping system guidance group (KODEX group, n = 20) and conventional two-dimensional perspective group (standard group, n = 20). The ablation time, operation time, fluoroscopy time, fluoroscopy dose, contrast agent dosage and follow-up data were compared between the two groups. Besides, the feasibility and accuracy of the dielectric sensing system in evaluating pulmonary vein (PV) occlusion in patients with AF during CB ablation were verified. All pulmonary veins were being isolated. The ablation time (36.40 ± 6.72 min vs 35.15 ± 6.29 min, P > 0.05) and the operation time (64.20 ± 11.82 min vs 66.00 ± 13.18 min, P > 0.05) were not statistically different in the two groups. The standard group has longer fluoroscopy time, dose and contrast medium dosage. There were significant differences in fluoroscopy time (532.30 ± 72.83 s vs 676.25 ± 269.33 s, P < 0.05), fluoroscopy dose (110.00 ± 28.64 mGy vs 144.68 ± 66.66 mGy, P < 0.05), and contrast medium dosage (71.90 ± 5.97 ml vs 76.05 ± 5.93 ml, P < 0.05) between the two groups. The learning curves of the first 5 patients and the last 15 patients in the KODEX group were compared. There was no statistical difference in the ablation time (36.80 ± 8.56 min vs 36.27 ± 6.34 min, P > 0.05) or the operation time (69.00 ± 5.00 min vs 62.60 ± 13.10 min, P > 0.05); however, compared to the first 5 patients, fluoroscopy time (587.40 ± 38.34 s vs 513.93 ± 73.02 s, P < 0.05), fluoroscopy dose (147.85 ± 35.19 mGy vs 97.39 ± 8.80 mGy, P < 0.05) and contrast medium dosage (79.60 ± 1.14 ml vs 69.33 ± 4.45 ml, P < 0.05) were significantly decreased. Using pulmonary venography as the gold standard, the sensitivity, specificity of the completely occlusion in KODEX group was 93.6% (95% CI 85–97.6%) and 69.6% (95% CI 54–81.8%); and the sensitivity, specificity of the small leak in KODEX group was 93.1% (95% CI 82.4–97.8%) and 82.0% (95% CI 65.9–91.9%). During an average follow-up of (9.90 ± 1.06) months, there was no statistical difference in arrhythmia recurrence and antiarrhythmic drugs taking after CB ablation between the two groups (P > 0.05). Using the KODEX-EPD system, the CB ablation procedure can correctly evaluate the PV occlusion, and significantly reduce fluoroscopy exposure and contrast medium without significantly increasing the operation time. | PMC10746707 |
Introduction | arrhythmias, death, peripheral vascular embolism, stroke | ARRHYTHMIAS, ATRIAL FIBRILLATION (AF), STROKE | Atrial fibrillation (AF) is one of the most common arrhythmias in the clinic, which is related to the increased risk of death, stroke, and peripheral vascular embolism. It is estimated that by 2050, China will have 5.2 million men over 60 years old and 3.1 million women with AF, which is 2.3 times the projected prevalence rate in the United StatesWith the continuous expansion of clinical indications and continuous updating of clinical evidence, catheter ablation of AF has been regarded as a first-line rhythm control therapy to improve symptoms in patients with symptomatic AF. According to the current 2020 ESC/EACTS guidelinesThe proximal sealing technique (PST) can ensure that the cryoballoon (CB) is ablated in the vestibule of PV, which is safer and more effectiveThe KODEX-EPD system (EPD Solutions, a Philips Company), as a novel, dielectric three-dimensional mapping system, has recently gained widespread attention because of its unique occlusion verification software to facilitate CBA procedureBaseline tool of KODEX-EPD system: (Injection tool of KODEX-EPD system: (The flow chart of CB ablation surgery under the guidance of KODEX-EPD.In this paper, a randomized controlled study was conducted in 40 consecutive patients with the indication of CB ablation of AF in a single center to investigate and evaluate the feasibility of CB ablation guided by the KODEX-EPD system. Furthermore, we intend to assess the feasibility of KODEX guided PST in CB procedures. | PMC10746707 |
Methods | PMC10746707 | |||
Study population | drug-refractory paroxysmal, atrial appendage occlusion, non-cardiac, hemorrhagic stroke, valvular abnormalities, atrial appendage thrombus, intracardiac thrombus, acute coronary syndrome, liver and kidney disease | HEMORRHAGIC STROKE, THYROID DISEASE, SEVERE LEFT VENTRICULAR HYPERTROPHY, HEMATOLOGICAL DISEASES, PERSISTENT ATRIAL FIBRILLATION, ELECTROLYTE DISORDER, BLEEDING TENDENCY, SECONDARY, INTRACARDIAC THROMBUS, ACUTE CORONARY SYNDROME | Patients scheduled for CB ablation of AF in the Department of Cardiac pacing in the first affiliated Hospital of Xinjiang Medical University from August 2021 to July 2022 were randomly divided into the standard group and the KODEX group. All patients understand the indications and risks of the operation before the operation, and sign the operation written consent form. And informed written consent has been obtained from all participants and/or their legal guardians. The same operator team performed CB ablation of AF on all 40 patients. The baseline characteristics of patients, procedure data were analyzed. Patients with previous ablation history, significant valvular abnormalities, and intracardiac thrombus were excluded from the study. Inclusion criteria: patients with paroxysmal AF or persistent AF whose duration is less than 12 months, according to the existing quality regimen, patients with AF need CB ablation: the main inclusion conditions are: (1) 18 years old ≤ age ≤ 85 years old; (2) symptomatic patients with drug-refractory paroxysmal or persistent atrial fibrillation; (3) patients who understand the purpose of the research, voluntarily participate in the research and sign the informed written consent are suitable. Exclusion criteria: those with any of the following criteria were excluded: (1) valvular AF or AF secondary to electrolyte disorders, thyroid disease, or other reversible non-cardiac causes; (2) previous history of left atrial ablation or surgery (including left atrial appendage occlusion); (3) left ventricular ejection fraction (LVEF) < 40%, or NYHA cardiac function grade III and IV or left atrial diameter ≥ 55 mm; (4) left atrial or left atrial appendage thrombus; (5) moderate to severe left ventricular hypertrophy (wall thickness > 1.5 cm); (6) patients with hemorrhagic stroke within 3 months; (7) patients with severe liver and kidney disease (ALT ≥ 3ULN or eGFR < 50 ml/min); (8) patients with obvious bleeding tendency and hematological diseases; (9) patients with acute coronary syndrome or patients who need stent implantation; (10) the participants have participated in clinical trials of other drugs or devices in the same period. | PMC10746707 |
CB ablation procedure | atrial appendage thrombus | All patients received a detailed preoperative evaluation, including medical history, physical examination, necessary laboratory examination, 12-lead ECG, cardiac ultrasound, left atrial and PV 3D reconstruction CT examination to understand the anatomical structure of the left atrium and PV. Left atrial appendage thrombus was excluded by transesophageal 3D echocardiography. All patients knew the indications and risks of the operation before the operation and signed the operation written consent form. The flow chart of this study is shown in Fig. All the procedures were conducted in local anesthesia with mild sedation. After access to the LA with the Brockenborough needle and an 8.5-French Swartz sheath (SL1; St. Jude Medical, MN), a 28-mm CB catheter (Arctic Front Advance; Medtronic Inc., MN) was introduced into the LA via a 12F steerable sheath (FlexCath; Medtronic Inc.). | PMC10746707 | |
Standard group | PNP | PHRENIC NERVE PARALYSIS, LEAKAGE | The achieve electrode was sent into the target PV for recording the PV potential, the CB was inflated in the left atrium, the filled CB was pushed along the Achieve electrode to the target PV orifice for occlusion, and the contrast medium was injected into the hollow lumen of the CB catheter, and then observed under fluoroscopy. If there is no contrast medium leakage into the left atrium, the balloon is considered to be well-occluded. PST is used to retreat the CB properly, observe the slight leakage of the contrast medium, and determine that the CB is located in the vestibule of the PV. When the second-generation balloon is used for freezing, the freezing time is 180 s, one freezing/thawing cycle at a time. If the balloon temperature is lower than − 55 °C, the freezing will be terminated immediately. After each freezing, achieve electrode was used to evaluate the electrical isolation of PV. CB ablation is usually performed in the order of left superior pulmonary vein (LSPV), left inferior pulmonary vein (LIPV), right superior pulmonary vein (RSPV), and right inferior pulmonary vein (RIPV). To prevent phrenic nerve paralysis (PNP), during CB ablation of the right pulmonary vein, the 4-pole electrode was sent to the superior vena cava to continuously pace the phrenic nerve. The assistant placed the hand on the patient's abdomen or observed the diaphragm movement under fluoroscopy. If it is found that the diaphragm movement weakens or disappears, it is necessary to stop freezing immediately. The endpoint of the operation was the electrical isolation of all PVs. If the electrical isolation of PV cannot be achieved after freezing 3–4 times, a radiofrequency (RF) ablation catheter should be used for supplementary ablation. | PMC10746707 |
KODEX group | proximal occlusion, partial occlusion | Mapping of the LA and PVs was performed with a circular mapping catheter (Achieve; Medtronic Inc.). The LA was reconstructed using the mapping catheter with the guidance of the 3-dimentional navigation system (KODEX-EPD Navigation system, version 1.4.8a). The anatomic sites of LSPV, LIPV, RSPV, RIPV, and superior vena cava (SVC) were marked. Then the Achieve electrode was sent into the target PV for mapping and recording PV potential. The CB was inflated in the left atrium, and the CB was pushed along the Achieve electrode to the target PV orifice for occlusion.The KODEX Occlusion assessment tools include the baseline tool and injection tool. In the baseline tool, the occlusion status was real-timely visualized as a colored-wheel in which green indicated optimal contact whereas red indicated sub-optimal contact. In injection tool, the occlusion status was depicted through the injection curve after a single injection of contrast. Optimal occlusion was achieved if the last quarter of the injection curve remained in the upper half. Otherwise, various leaks might be present. When multiple red electrodes show partial occlusion, balloon operation can be displayed in real-time to achieve better and complete occlusion without multiple injections of contrast agent and angiography. After all the green electrodes showed by the baseline tool, the proximal occlusion was evaluated by injection and X-ray, and CB ablation was performed after meeting the conditions. Among them, under the guidance of KODEX-EPD, the performance of PST is mainly presented by injection tool. The injection tool's dissipation curve is divided into three segments (Fig. PST under the guidance of KODEX-EPD: ( | PMC10746707 | |
Data collection | All patients who underwent CB ablation of AF were routinely collected clinical research data, including sex, age, past medical history, electrocardiogram, cardiac ultrasound parameters, total ablation time, total operation time, intraoperative fluoroscopy time, intraoperative fluoroscopy dose, intraoperative contrast agent dosage, follow-up data etc. | PMC10746707 | ||
Statistical method | Continuous variables were described as the as mean ± SD for normally distributed data and median (25–75% quartile) for non-normally distributed data. The comparison between the two groups was performed by two independent samples t-test, and the counting data was analyzed by chi-square test. Using the pulmonary venography as the gold standard, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated including the 95% confidence interval (CI) based on a binomial distribution. All tests were 2-tailed, and a statistical significance was established at P < 0.05. All analyses were performed using SPSS software (version 27.0 SPSS, Inc., Chicago) (Fig. Flowchart of this study. | PMC10746707 | ||
Ethical approval | All experimental schemes have been approved by Ethics Committee of the first affiliated Hospital of Xinjiang Medical University and all the procedures being performed were part of the relevant guidelines and regulations (Ethics approval number: 20180622-06). | PMC10746707 | ||
Informed consent | All patients understand the indications and risks of the operation before the operation, and sign the operation written consent form. And informed written consent has been obtained from all participants and/or their legal guardians. Besides, this study is carried out in accordance with the principle of the Declaration of Helsinki. | PMC10746707 | ||
Result | PMC10746707 | |||
Baseline characteristics | A total of 40 patients (27 males and 13 females) were included in this study, mean age was 67.43 ± 10.69 years. The baseline characteristics of the standard group and the KODEX group were shown in Table Baseline characteristics. | PMC10746707 | ||
Procedure data | 20 cases were treated with the KODEX-EPD system and 20 cases with conventional fluoroscopy. The total ablation time and total operation time in KODEX group were (36.40 ± 6.72 min vs 35.15 ± 6.29 min, P > 0.05) and (64.20 ± 11.82 min vs 66.00 ± 13.18 min, P > 0.05), there was no significant difference between the two groups. The intraoperative fluoroscopy time was (532.30 ± 72.83 s vs 676.25 ± 269.33 s P < 0.05), the intraoperative fluoroscopy dose was (110.00 ± 28.64 mGy vs 144.68 ± 66.66 mGy, P < 0.05), and the intraoperative contrast agent dosage was (71.90 ± 5.97 ml vs 76.05 ± 5.93 ml, P < 0.05)in the KODEX group compared with the routine group (Table Intraoperative related indicators. | PMC10746707 | ||
Learning curve comparison | In the KODEX group, the first 5 patients were compared with the latter 15 patients in terms of the learning curve (Table Comparison of learning curve.Learning curve of fluoroscopy time.Learning curve of fluoroscopy dose.Learning curve of contrast agent dosage.In the standard group, the first 5 patients were compared with the latter 15 patients in terms of the learning curve (Table Comparison of learning curve.Learning curve of fluoroscopy time.Learning curve of fluoroscopy dose.Learning curve of contrast agent dosage. | PMC10746707 | ||
Performance of KODEX-EPD injection in evaluating PV occlusion | leaks, postoperative arrhythmia, PV occlusion | RECURRENCE, SENSITIVITY | In this study, 79 PV occlusions in 20 patients with KODEX-EPD were analyzed. All PVs were electrically isolated. Compared to the results of the X-ray evaluation, a total of 78 times (42.8%) were completely occluded, 58 times were small leaks (31.9%), and 46 times were large leaks (25.3%). Overall, when the X-ray results indicate completely occluded, the sensitivity of KODEX-EPD injection tool in predicting the outcome of PV occlusion was 93.6% (95% CI 85–97.6%, P < 0.01), the specificity was 69.6% (95% CI 54–81.8%, P < 0.01), and the positive predictive value was 83.9% (95% CI 74.1–90.6%, P < 0.01). The negative predictive value was 86.5% (95% CI 70.4–90.6%, P < 0.01). The evaluation results of the specific four PVs are shown in Table Sensitivity and specificity of the Injection tool for PV occlusion verification.All patients were followed up routinely after operation, with an average follow-up of (9.90 ± 1.06) months. Follow-up standard group and KODEX group for postoperative arrhythmia recurrence and whether to continue taking antiarrhythmic drugs, the follow-up results are shown in Table Follow-up data. | PMC10746707 |
Discussion | cataracts, malignancies, musculoskeletal injuries, allergies | RENAL INSUFFICIENCY, ADVERSE EVENTS, SKIN DISEASES, MALIGNANCIES, HEART FAILURE, ALLERGIES, LEAKAGE, CATARACTS, BENDING, COMPLICATIONS | The KODEX-EPD mapping system creates high-resolution cardiac anatomical images by utilizing the unique dielectric properties of biological tissues. When compared to other mapping system, this system has the advantage of non-contact modeling, which can more accurately locate the PV and related accessory structures, increasing the operation's success rate (Fig. 3D reconstruction image of the heart and modeling image of KODEX-EPD mapping and navigation system.Although the proximal seal technique (PST) is a recommended method to avoid ablation within the tubular portion of the PV, there is no qualitative description of the workflow. The use of PST to achieve the vestibular site of PV ablation without a large leakage has not been well described. Thus, in this study, we assessed the feasibility of using a new mapping system, KODEX-EPD, to standardize PST in a group of patients. During the ablation of PV with PST, the injection curve for the KODEX-EPD system displayed three-stage characteristics as follows: the first part of the curve climbed rapidly; the second part of the curve could maintain a high position or a lower slope; and the third part of the curve decreased slowly and eventually stabilized at about half of the peak value. After our center regularly used it to guide the CB ablation of AF, our data indicated that KODEX-EPD system had good sensitivity and specificity compared to X-ray results when the X-ray results showing complete occlusion. In the case of small leakage of X-ray results, the sensitivity and specificity of KODEX-EPD system evaluation results were 93.1% and 82% respectively, which preliminarily proved the value and potential of the KODEX-EPD 3D navigation system in CB ablation surgery. The sensitivity and specificity of the right pulmonary system is slightly lower than those of the left lung, possibly due to the influence of catheter operation. Because a second-generation Medtronic balloon was used in this study, the catheter operation required more space than a fourth-generation balloon or RF ablation catheter to achieve balloon bending and movement among other operations. In terms of catheter and sheath operation, the right PV requires more catheter and sheath operation, and the Achieve electrode is frequently sent into the depths of the PV to meet the requirements of balloon placement and stable position, which may affect the function of occlusion evaluation based on the dielectric principle.Fluoroscopy exposure has a significant negative impact on patients and operators, these risks include acute and subacute skin diseases, musculoskeletal injuries, cataracts, malignancies and genetic defectsSome patients with renal insufficiency, elderly patients with heart failure, and contrast agent allergies may be unable to undergo CB ablation. However, according to one studyOur study further investigated the learning curves of the KODEX-EPD system. When compared to the first five patients, the intraoperative fluoroscopy time, fluoroscopy dose, and contrast agent dosage were all significantly reduced. This demonstrates that after completing the learning curve, intraoperative fluoroscopy exposure and contrast agent dosage can be reduced further. Besides, during the medium-and long-term follow-up, there were no operation-related complications. We can conduct longer follow-up to further verify the safety and effectiveness of KODEX-EPD in CB of AF.As a result, we can conclude that the occlusion evaluation tool has a high sensitivity and specificity for CB ablation. After passing the learning curve, it is possible to reduce fluoroscopy time, fluoroscopy dose, and contrast agent dosage. With the substitution of saline for contrast agent, allowing for 3D visualization of cardiac structure and CB ablation with a low contrast agent dose, the KODEX-EPD system will have high value in the future.We hope that in the future, KODEX-EPD will be able to provide real-time information about the anatomical structure of the heart and PVs, as well as the location of the balloon, through a simpler and more intuitive graphical interface and more accurate 3D navigation. It can assist operators in correctly evaluating the effect of PVI via green electrophysiology, increasing the success rate of AF CB ablation and decreasing the occurrence of adverse events. | PMC10746707 |
Study limitations | BLIND | First, this study was conducted in a single center and included a small number of patients. This might limit the universality of research results. A larger, prospective, multicenter study could shed more light on the role of KODEX-EPD in improving AF treatment via CB ablation. Second, in this study, operators can master the KODEX-EPD system skillfully through the learning curve of 5 cases, and there may be differences among different operators in different centers. Third, this experiment cannot blind the operator, so there may be bias. | PMC10746707 | |
Author contributions | RECRUITMENT | S.W.: analyzed the data, interpreted the results, and drafted the manuscript. L.W., S.Y.: contribute data acquisition, data analysis and interpretation. W.S., Y.H., L.W., F.W.: responsible for the statistics, data management, drafted tables and figures. J.Z., Q.X., Z.T., J.X., Y.G.: contributed to patient recruitment, data acquisition and analysis result. B.T., X.Z.: review and revision of papers. Y.L.: designed the study protocol, substantially contributed to the conception of the study, review and revision of papers, Supervise and guide the writing of papers. All authors wrote and approved the manuscript. | PMC10746707 | |
Funding | Science Fund for Distinguished Young Scholars of Xinjiang Autonomous Region, award number: 2022D01E22. Key R&D Program of Xinjiang Uygur Autonomous Region (2022B03023). National Natural Science Foundation of China, award number: 81873487. | PMC10746707 | ||
Data availability | The datasets generated during and/or analyzed during the current study are available by request. | PMC10746707 | ||
Competing interests | The authors declare no competing interests. | PMC10746707 | ||
References | PMC10746707 | |||
Introduction | tumor, intrahepatic cholangiocarcinoma, Biliary tract cancer, aggressive adenocarcinomas, Above phenomenon inspired the current study, extrahepatic cholangiocarcinoma | EXTRAHEPATIC CHOLANGIOCARCINOMA, GALLBLADDER CANCER, TUMOR, MALIGNANCIES, INTRAHEPATIC CHOLANGIOCARCINOMA | Biliary tract cancer (BTC) is a heterogeneous spectrum of high aggressive adenocarcinomas including gallbladder cancer, intrahepatic cholangiocarcinoma (ICC), and extrahepatic cholangiocarcinoma (ECC).Since ICC is quite different from other BTC in molecular phenotype, immune microenvironment and prognosis, it is of great significance to explore new treatments of pure ICC.Recent evidence suggests that tumor eradication and improved survival can be promoted by anti-PD-1 antibodies, and blockade of PD-1/PD-L1 pathways reinvigorates antitumor immunity. Monotherapy and combination therapy with anti-PD-(L)1 have achieved an improved tumor response rate and extended survival times for a spectrum of advanced malignancies,Above phenomenon inspired the current study, a single-center, open-label, single-arm, phase 2 investigation to investigate the efficacy and safety of the anti-PD-1 antibody toripalimab in combination with lenvatinib and GEMOX chemotherapy for advanced ICC. Toripalimab is a humanized anti-PD-1 IgG4 monoclonal antibody approved for clinical trials by the US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA). | PMC10020443 |
Results | PMC10020443 | |||
Expression of PD-L1 and whole-exome sequencing (WES)-based mutation profiling of tissues | tumor, tumors | MICROSATELLITE INSTABILITY HIGH, TUMOR, TUMORS | Immunohistochemical (IHC) examination of PD-L1 and PD-1 expression was performed. A total of 46.7% (14/30) of patients had tumors that were PD-L1 positive [tumor area positivity (TAP) ≥ 1% was defined as positive, proportion of tumor and/or immune cells with PD-L1 staining at any intensity].Representative case with different expression of PD-L1 protein and DDR mutation of each patient. To further investigate the molecular mechanism of action of the combined therapy in advanced ICC, WES were analyzed in 30 subjects. A total of 1564 nonsynonymous mutations were observed in 30 patients. The median tumor mutation burden (TMB) was 0.985 Muts/Mb (range, 0.08–31.82 Muts/Mb). Two patients presented with microsatellite instability high (MSI-h), and three patients had MSI-l (Table | PMC10020443 |
Discussion | DDR, nausea, gallbladder cancer, tumor, neutropenia, fatigue, vomiting,, anemia, heterogeneous disease, abnormal ECG | LEUKOCYTOPENIA, TUMOR, GALLBLADDER CANCER, NEUTROPENIA, THROMBOCYTOPENIA, DISEASE, ANEMIA, METASTASES, ADVANCED BILIARY TRACT CANCER | This study was the first to demonstrate that toripalimab in combination with lenvatinib and GEMOX chemotherapy yielded a high ORR (80%) and a median OS of 22.5 months in 30 subjects with locally advanced and metastatic ICC. Grade 3 or higher AEs were observed in 17 subjects and were easily manageable.Recently, many studies have investigated the clinical effects and safety of anti-PD-1/PD-L1 antibodies as first- and second-line therapy for BTC. A multicenter, open-label, phase 1 trial showed that nivolumab (PD-1 inhibitor) monotherapy had anti-tumor activity in Japanese patients with advanced BTC, yielding an ORR of 3.3%, a median OS of 5.2 months, and a median PFS of 1.4 months, while combination therapy of nivolumab and chemotherapy achieved more survival benefits in terms of higher ORR (33.3%), longer median OS (15.4 months), and median PFS (4.2 months).BTC is, however, a heterogeneous disease; ICC, ECC, and gallbladder cancer have distinct sites of origin, molecular phenotypes, and manifestations. The data from comprehensive analysis of Advanced Biliary Tract Cancer (ABC)-01, -02, and -03 studies also showed that patients with advanced ICC or liver-only ICC had a better OS-benefit from chemotherapy compared with other BTC.A combination therapy of lenvatinib with anti-PD-1 antibody also has utility in BTC. The LEAP-005 study recently showed that this combination yields an ORR of 10% as second-line treatment of advanced BTC.In addition to being beneficial, our triple treatments resulted in AEs that were tolerable and manageable. The common AEs observed in this study were increased AST or ALT levels, thrombocytopenia, anemia, neutropenia, leukocytopenia, abnormal ECG, vomiting, nausea, and fatigue, which were similar to those reported in a previous study of chemotherapy and an anti-PD-1 antibody.All patients with advanced ICC included in this study had stage IIIA disease or higher at baseline: 16.7% (5/30) had stage IIIA disease, 43.3% (13/30) had stage IIIB disease, and 40% (12/30) had stage IV disease. This means that the severity of the disease in the present study was similar to that in the ABC-02 trial (104/410 patients had locally advanced disease and 306/410 had metastases), which tested chemotherapy alone. Our combined therapy resulted in a much higher ORR and better mOS for advanced ICC than standard chemotherapy or any pairwise combination of PD-1 inhibitor with lenvatinib or chemotherapy. Moreover, this study showed that patients with positive staining for PD-L1in tumor cells tended to have a good response to this triple combination therapy. More importantly, our results also showed that patients presented with DDR-related gene mutations had a better response to this regimen than those without mutations. DDR is an important mechanism that enables cell survival in the face of genomic instability, replicative stress, and irreparable damage.This study has a few limitations. First, all patients were from a single center, potentially introducing an unknown selection bias and reducing the generalizability of the study. In particular, only relatively young patients (median 56.5 y, range 25–73 y) and those with good performance status were enrolled in this study, which may result in selection bias. Second, this was a single-arm, single-center and phase 2 trial and was designed without a control, which might weaken the reliability of evidence and increase the comparison error. Finally, the sample size in present trial was relatively small, which may result in selection bias and influence the estimation of ORR, PFS, and OS.Despite these limitations, this phase 2 study is, to the best of our knowledge, the first prospective trial of a PD1 inhibitor combined with GEMOX chemotherapy and lenvatinib for pure and advanced ICC patients. This study provides believable data demonstrating high efficacy, controllable AEs, and feasibility of this triple-combination therapy for ICC, which should be further explored in future well-designed prospective trials. To that end, we recently have developed a multicenter, double-blinded, randomized, phase 3 study to confirm the high efficacy of this combination therapy in patients with advanced ICC, and obtained NMPA approval (No 2021LP01825). That trial is also registered at Clinicaltrials.gov (number NCT05342194). It is expected that this new study will start to enroll patients in a few months. | PMC10020443 |
Materials and methods | PMC10020443 | |||
Study design and participants | tumor | MAY, TUMOR | A single-center, single-arm, open-label, phase 2 study was designed to evaluate the efficacy and safety of toripalimab in combination with lenvatinib and GEMOX chemotherapy as first-line therapy for unresectable and metastatic ICC in Zhongshan Hospital. Forty-two candidates were screened, and 30 eligible subjects were enrolled in this trial from May 15, 2019, to October 24, 2019 (Fig. GEMOX chemotherapy is a common therapeutic schedule for advanced BTC, including ICC. The safety of combination treatment of lenvatinib with anti-PD1 antibody for patients with advanced ICC was acceptable.The research protocol was approved by the Zhongshan Hospital review board and independent ethics committees (B2019-078R) and was conducted following the Declaration of Helsinki and Good Clinical Practice Guidelines. Each subject was required to sign the informed consent form before enrollment. WES of DNA from fresh biopsy tumor tissues was performed as reported, | PMC10020443 |
Procedures | Eligible subjects received intravenous GEMOX chemotherapy (Q3W) including oxaliplatin (85 mg/m | PMC10020443 | ||
Outcomes and assessments | PD, death | TUMOR RECURRENCE | The primary endpoint of this trial was ORR, including complete and partial responses as determined by the investigator and independent post hoc analysis. Secondary endpoints included OS (dated from the first treatment with study medication to the date of death owing to any cause or censored on the date of last follow-up), PFS (dated from the first treatment with study medication to the first documented PD or death owing to any cause, whichever occurred first; defined as tumor recurrence or death owing to any cause in the patients who received resection), 1-year overall survival rate, DoR, and DCR (including CR, PR, and SD). These endpoints were inputs into the efficacy and safety profiles assayed by the investigators or by the two independent radiologists in the post hoc analysis. | PMC10020443 |
IHC analysis and WES analysis | Tumor | SOMATIC MUTATION, TUMOR, MUTATION | Tumor tissues of each patient were obtained by biopsy and embedded by paraffin. The presence of PD-L1 and PD-1 was investigated by IHC staining with corresponding primary antibody as previously.DNA in paraffin-embedded biopsy tissues from each subject was extracted. Sequencing libraries were prepared and whole-exome-sequenced according to the instructions of manufacturer. The raw data of WES have been uploaded in the OMIX, China National Center for Bioinformation/Beijing Institute of Genomics, Chinese Academy of Sciences (Mutation calling by Trimmomatic was used as quality control of FASTQ. Paired-end reads were then aligned to the human reference genome (hg19) using the Burrows–Wheeler aligner (BWA). Somatic mutations were first acquired for each sample. All single nucleotide variants (SNVs)/indels were annotated by ANNOVAR, and each SNV/indel was manually examined in the Integrative Genomics Viewer (IGV). Copy number variations (CNVs) were analyzed using in-house software. Mutations in 15 genes related to microsatellites (MS) were analyzed, and ≥30% of mutations were defined as MSI-h. Mutations in DDR-related genes were analyzed. | PMC10020443 |
Statistical analysis | tumor | TUMOR, DISEASE CHARACTERISTIC | The sample size of this trial was calculated according to an exact single-stage design. A total ORR ≤ 14% (the ORR was 13.5% in our previous observational study on GEMOX for advanced ICC, unpublished data) was considered not clinically meaningful; an overall response ≥40% was considered promising. Thirty patients were needed to achieve a power of 90% with a significant level of 5%. All efficacy and safety endpoints were analyzed in all subjects who obtained at least one dose of toripalimab.The ORRs and 95% confidence intervals (CIs) were determined by the Clopper-Pearson method. We calculated the number of subjects with a best tumor response and the DCR. We calculated the maximum percentage change in the sum of the diameters of the target lesions for each subject (from baseline) and pictured these parameters as a waterfall plot. We used the Kaplan‒Meier method to summarize OS, PFS, and DoR. Medians and 95% CIs (calculated with the Brookmeyer-Crowley method) are presented. Further, 95% CIs for OS and PFS rates were determined based on the Greenwood formula. Post hoc ORR subgroup analyses stratified by selected demographic and disease characteristics were conducted accordingly. Exploratory subgroup analysis stratified by intensity of tumor PD-L1 and DDR-related gene mutation was performed.All data were analyzed by the aid of SPSS 19.0 software (IBM, Armonk, NY, USA) and R software version 4.1.0 (The R Foundation, Vienna, Austria). This trial is registered with Clinicaltrials.gov, number NCT03951597. | PMC10020443 |
Supplementary information |
supplemental tableThese authors contributed equally: Guo-Ming Shi, Xiao-Yong Huang, Dong Wu, Hui-Chuan SunThese authors jointly supervised this work: Guo-Ming Shi, Xiao-Yong Huang, Dong Wu, Hui-Chuan Sun | PMC10020443 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41392-023-01317-7. | PMC10020443 | ||
Acknowledgements | DISEASE | We appreciate the patients and their families for their support in this study. This trial was partly supported by National Natural Science Foundation of China (81972232, 81830102, 82150004); Clinical Research Plan of SHDC (SHDC‑2020CR1003A, SHDC-2020CR1022B); National Key Research and Development Program of China (2019YFC1316000, 2019YFC1315800, and 2019YFC1315802), the Key Disease Joint Research Program of Xuhui District (XHLHGG202103), the Clinical Medicine Research Pilot Project of Shanghai Medical School of Fudan University (2020, 21DGF501035/00), the Shanghai Municipal Natural Science Foundation (20JC1419103, 21ZR1412200), Beijing Mutual Care Public Welfare Foundation (GDXZ-08-05), Sanming Project of Medicine in Shenzhen (SZSM202003009), and Shanghai Municipal Key Clinical Specialty Construction Project (shslczdzk02401). The funders of the grant did not participate in the process of trial, including research design, raw data collection, statistical analysis, data interpretation, paper writing, and submission. | PMC10020443 | |
Author contributions | J.Z. and J.F. contributed to conceptualization. J.Z., J.F., and G.S. contributed to methodology. G.S., X.H., D.W., G.Y., Y.J., Y.C., N.G., H.S., X.H., X.M., S.Q., X.Y., Q.G., C.L., Y.X., Y.H., Z.R., and J.S. contributed to collection of samples and clinical data. G.S., X.H., and F.L. contributed to formal data analysis. G.S., X.H., J.Z., H.S., J.Z., and J.F. contributed to paper writing. Each author has read and approved the paper. All authors are eligible for the data of the study and had the right to decide the submission and publication. | PMC10020443 | ||
Data availability | The dataset generated during the present study can be obtained from the corresponding author with a reasonable request. | PMC10020443 | ||
Competing interests | The authors declare no competing interests. | PMC10020443 | ||
References | PMC10020443 | |||
Introduction | ® | laryngoscopy and tracheal intubation induce catecholaminergic release. Our study aimed to evaluate the hemodynamic impact of orotracheal intubation by McGrath® compared to the Macintosh laryngoscope in the elderly. | PMC10504445 | |
Methods | orotracheal intubation | HEART, COMPLICATIONS | we conducted a prospective randomized clinical trial that included elderly patients proposed for a scheduled surgery under general anesthesia with orotracheal intubation and divided into 2 groups: patients who were intubated using the McGrath® (group V) and patients who were intubated using the Macintosh direct laryngoscope (group M). Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial blood pressure (MAP), were recorded before induction of anesthesia (baseline), and at 1 min, 3 min, and 5 min after intubation. Our outcomes were the increase of SBP (∆ SBP), MAP (∆ MAP), and HR (∆ HR) between the two groups, during the 5 minutes following the start of the orotracheal intubation, intubation time and the incidence of its related complications. | PMC10504445 |
Results | ventricular arrhythmias, postoperative sore throat | VENTRICULAR ARRHYTHMIA | sixty patients were included and randomized into 2 groups of 30. The average age of our sample was 70±6 years with a sex ratio of 1.22. Most of the patients were operated on for orthopedic, urologic, or abdominal surgery. There were no statistically significant differences between the two groups in terms of demographic characteristics and the duration of anesthesia (p> 0.05). The intubation time was significantly increased in group M (p≤0.001). There was a significant difference in SBP, MAP, and HR values at 1 min after orotracheal intubation compared with the baseline values in Group V(P<0,05) and Group M (p < 0.05). There was a significant increase in the first minute after tracheal intubation in terms of SBP (151±42 vs 134.5±26 mmHg, p=0.012), MAP (114±4 vs 102±17 mmHg, p=0.015), DBP (89±32 vs 84±16 mmHg, p=0.01), and HR (99.5±10 vs 94.5±2 b/min, p=0.008) when group M was compared to group V. The ∆SBP was significantly different between group M (∆SBP = 36.2±23.5mmHg) and group V (∆SBP= 30.77±21.6mmHg) (p = 0.005). There were 4 ventricular arrhythmias in group M versus zero in group V (p <0.0001). The postoperative sore throat was significantly decreased in group M vs V (p=0.036). | PMC10504445 |
Conclusion | the McGrath® videolaryngoscope decreased the hemodynamic fluctuations due to endotracheal intubation in elderly patients. | PMC10504445 | ||
Introduction | hypertension, tachycardia | HYPERTENSION | Direct laryngoscopy with the Macintosh laryngoscope is commonly used in orotracheal intubation. Laryngoscopy and intubation of the trachea could induce hemodynamic variations like hypertension and tachycardia [Alongside direct laryngoscopy, indirect laryngoscopy is booming since the beginning of the 21 | PMC10504445 |
Discussion | arrhythmia, orotracheal intubation, heart complications, ® | ARRHYTHMIA, COMPLICATIONS, VENTRICULAR EXTRASYSTOLES | We conducted a prospective randomized clinical trial to evaluate the hemodynamic impact of orotracheal intubation by McGrath® compared to the Macintosh laryngoscope in the elderly patients proposed for a scheduled surgery under general anesthesia with orotracheal intubation. We included 60 patients and divided them into 2 equivalent groups: patients who were intubated using the McGrath® (group V) and patients who were intubated using the Macintosh direct laryngoscope (group M). This study showed that the McGrath® videolaryngoscope decreased hemodynamic fluctuations and complications due to endotracheal intubation in elderly patients with fewer heart complications or postoperative laryngeal morbidities.Over the last few decades, several studies listed in the anesthesia literature have addressed the hemodynamic impact of laryngoscopy and orotracheal intubation. In 1951, King In our study, the intubation time obtained with the McGrath® was greater than that obtained with the Macintosh laryngoscope. In a study of 120 patients, Kaur Mechanical stimulation of pharyngeal and laryngeal proprioceptors during laryngoscopy and tracheal intubation induces the secretion of cortisol and catecholamines, and therefore a subsequent increase in HR (by about 20%), blood pressure (BP) (40-50%), pulmonary capillary pressure (Pcap) and intracranial pressure (ICP) [We noted a tendency for arrhythmia (ventricular extrasystoles) in group M when compared to group V. This may be due to a greater adrenergic discharge caused by Macintosh laryngoscopy, related to the intensity of the force applied [ | PMC10504445 |
Conclusion | In elderly patients, the McGrath videolaryngoscope, in comparison to the Macintosh direct laryngoscope, was proven to decrease the hemodynamic alterations that are due to tracheal intubation with less postoperative laryngeal morbidity. However, the duration of the intubation is significantly shorter with the Macintosh direct laryngoscope. | PMC10504445 | ||
Competing interests | The authors declare no competing interests. | PMC10504445 | ||
Authors' contributions | Conception and design: Mahdi Fourati, Salma Ketata. Acquisition of data: Mahdi Fourati, Karim Bouzid. Analysis and interpretation of data: Mahdi Fourati, Salma Ketata, Imen Zouche, Moncef Sallemi. Drafting the article or revising it critically for important intellectual content: Mahdi Fourati, Salma Ketata, Rahma Derbel, Mariem Keskes, Moncef Sallemi, Souha Kallel, Sami Fendri, Amine Zouari, Imen Zouche, Hichem Cheikhrouhou. Final approval of the version to be published: Mahdi Fourati, Salma Ketata, Rahma Derbel, Mariem Keskes, Moncef Sallemi, Souha Kallel, Karim Bouzid, Sami Fendri, Amine Zouari, Imen Zouche, Hichem Cheikhrouhou. Guarantor of the study: Hichem Cheikhrouhou. All the authors have read and agreed to the final manuscript. | PMC10504445 | ||
Background: | E-sports require athletes to have high-speed reflexes and excellent memory skills. Whereas a single session of aerobic exercise has been shown to improve cognitive function, this paper aims is to investigate the effects of acute moderate-intensity aerobic exercise on the cognitive function of e-sports players and its time-course characteristics. | PMC10553036 | ||
Methods: | Thirty-four E-athletes were divided into 2 groups according to a random number table method, and 2 trials in a quiet physical fitness gym. The duration of each trial was approximately 1 hour. In the first trial: exercise group (64–76% of maximum heart rate for 30 minutes power cycling) and control group, cognitive function was tested, and results were automatically recorded before, immediately after, and 30 minutes after exercise using the human benchmark website ( | PMC10553036 | ||
Results: | In both trials, the exercise intervention group showed significant improvements in speed accuracy ( | PMC10553036 | ||
Conclusion: | Acute moderate-intensity aerobic exercise significantly enhanced the speed accuracy, visual reaction time, and instantaneous memory of eSports players, and the effect could be extended up to 30 minutes after exercise. | PMC10553036 | ||
1. Introduction | PROLIFERATION | E-sports have been attracting more and more attention, with the number of spectators reaching 495 million and the revenue reaching approximately $1.1 billion in 2020.The link between physical activity and the brain has been of interest for some time, with most studies examining the effects of low to moderate-intensity aerobic exercise and brain function. Aerobic exercise has also been reported to increase brain endothelial cell proliferation and angiogenesis.Acute aerobic exercise, also known as single-session exercise, lasting 10 to 60 minutes, is a type of exercise that uses aerobic metabolism to provide energy. It has been shown to affect cognitive function positively.Numerous pieces of evidence demonstrate the benefits of acute aerobic exercise, and there are numerous scientific studies on acute aerobic exercise interventions. However, although all their studies aimed to explore the effects of acute exercise on cognitive function in the general population, few studies have examined the effects of acute moderate-intensity aerobic exercise on the cognitive function of professional E-athletes. Most studies were limited to observing the immediate effects of acute aerobic exercise. They did not further explore the time-course characteristics of acute exercise.In summary, does a single bout of moderate-intensity physical exercise positively affect e-sports players’ cognitive functions, such as reaction time, accuracy, and visual memory? What are the time course characteristics of the impact on these cognitive functions? This study used laboratory experiments to observe the effects of acute moderate-intensity aerobic exercise on the cognitive function of e-sports players and to explore the time course characteristics of these effects. This benefit will allow eSports players to maintain excellent cognitive executive function after exercise, contributing to higher performance levels in competition. Also, given the benefits of acute aerobic exercise, the results of this experiment will help e-sports coaches or personal physicians to target better training and recovery integration training programs for e-sports players.We hypothesize that acute aerobic exercise intervention will improve e-sports players’ cognitive functions, such as reaction time, accuracy, and visual memory. The effects will exhibit specific time course characteristics. | PMC10553036 | |
2. Participant and methods | PMC10553036 | |||
2.1. Participants | illness | COLOR BLINDNESS | In October 2022, eligible E-athletes were openly recruited for the e-sports major at Shandong Sport University. Shandong Institute of Sports, the first higher education institution in China to offer an eSports undergraduate program, has high-quality E-athletes who are strictly different from ordinary healthy people. All subjects were E-athletes who had participated in relevant eSports tournaments and had previous extensive eSports real-world experience. The inclusion criteria are as follows:Good physical health with no history of illness or family diseases;Playing time exceeding 14 hours per week for 6 months;Voluntary participation in the study and ability to complete training according to the requirements;Right-handed.The exclusion criteria are as follows:Severe injury or unrecovered sports injury history;Recent taken any drugs that have exciting or paralyzing effects on nerves;Participation in similar experimental projects within 3 months;Unwillingness to participate in the study;Red-green color blindness.Sample size estimation was conducted based on the results of the pre-experiment regarding the Sequence memory test, Chimp test, Aim trainer test, Visual memory, and Reaction time. Sequence memory test (points): Experimental group (pre = 8.25 ± 1.50, post = 11.25 ± 0.96), control group (pre = 8.25 ± 1.26, post = 9.00 ± 1.41). Chimp test (points): Experimental group (pre = 8.00 ± 2.16, post = 10.50 ± 1.00), control group (pre = 8.50 ± 1.29, post = 8.75 ± 0.96). Aim trainer test (ms): Experimental group (pre = 614.75 ± 41.99, post = 484.75 ± 39.54), control group (pre = 548.50 ± 42.63, post = 531.25 ± 39.69). Visual memory (points): Experimental group (pre = 9.75 ± 0.96, post = 12.00 ± 0.82), control group (pre = 10.50 ± 1.73, post = 11.50 ± 1.39). Reaction time (ms): Experimental group (pre = 252.00 ± 39.27, post = 231.75 ± 30.36), control group (pre = 243.00 ± 17.61, post = 238.00 ± 12.83). After conducting a repeated measures analysis of variance, the effect sizes were found to be ηThe 34 participants were randomly divided into 2 groups of 17 people each. The randomization method is the random number table method, which uses a computer to generate a random number table containing 50 natural numbers in 10 rows and 10 columns, all randomized horizontally, vertically, or diagonally. First, 34 consecutive digits of a particular section were random selected from the random number table. Then the 34 subjects were numbered in the order of group entry and arranged in the order corresponding to the random numbers, specifying that those with odd corresponding random numbers entered Group 1 and those with even corresponding random numbers entered Group 2. Complete randomization of the groups can be achieved with this method.This study was conducted by the Helsinki Declaration and was approved by the Ethics Committee of Sports Science (approval number: 2022007). The responsible person informed the participants of the study content and procedures verbally and in writing. All participants were given written informed consent before voluntary participation in the study and signed a paper consent form. Participants were free to withdraw from the study without further consequences. | PMC10553036 |
2.2. Cognitive tasks | All cognitive tasks were tested using the Human Benchmark website ( | PMC10553036 | ||
2.2.1. Sequence memory test. | The sequence memory test assesses long-term memory. This study used sequence memory test from the Human Benchmark website ( | PMC10553036 | ||
2.2.2. Chimp test. | The Chimp test evaluates long-term memory. This study used Chimp test from the Human Benchmark website ( | PMC10553036 | ||
2.2.3. Aim trainer test. | The Aim trainer test evaluates speed and accuracy abilities. This study used Aim trainer test from the Human Benchmark website ( | PMC10553036 | ||
2.2.4. Visual memory test. | The Visual memory test evaluates memory ability. This study used Visual memory test from the Human Benchmark website ( | PMC10553036 | ||
2.2.5. Reaction time test. | The Reaction time test evaluates visual reaction time. This study used Reaction time test from the Human Benchmark website ( | PMC10553036 | ||
2.3. Experimental tools | HEART | The main experimental equipment used during the exercise intervention included: Lode Corival Aerobic Power Bike (Lode B.V., Groningen, Netherlands) and Polar RS400 Heart Rate Telemetry (including bracelet and chest strap) (Polar Electro Oy, Oulu, Finland), which monitored in real time the heart rate changes of the subjects during pre- and post-exercise sessions. The cognitive task tests were all required to be completed by the subjects using the specified Lenovo Legion R720 computer (Lenovo Group Limited, Beijing, China). | PMC10553036 | |
2.4. Exercise program | HRThe | Participants were randomly assigned to Group 1 and Group 2, and the test was divided into 2 experiments. In the first experiment, Group 1 used the control method (Group C), and Group 2 used the exercise intervention method (Group E). In the second experiment, the 2 groups were crossed over, meaning that Group 1 used the exercise intervention method (Group E) and Group 2 used the control method (Group C). The exercise intervention method first used the power bicycle for 30 minutes (5 minutes for warm-up activity). The exercise intensity was based on the latest rating standards for exercise intensity for healthy adults from the American College of Sports Medicine. The moderate-intensity exercise load was set to 64% to 76% of the individual’s maximum heart rate, with maximum heart rate (HRThe most commonly used form of exercise for acute aerobic exercise is power cycling, which has the advantage of being able to control heart rate by pedaling speed as a way to achieve moderate exercise intensity. The crossover of the intervention modality between the 2 groups of subjects in both trials was to verify the presence of a sequential effect and, thus, to more accurately verify the effect of acute moderate-intensity aerobic exercise on cognitive function. | PMC10553036 | |
2.5. Experimental procedure | First, inform the subjects of the experimental procedure and obtain their informed consent. To overcome the effects of subject response, inform the subjects before the experiment begins that this experiment is designed to measure the impact of a 1-time exercise on cognitive function. Then, have the exercise group subjects wear the heart rate telemetry device. In the first experiment: the first index test is performed before exercise, recorded as Time 0, followed by 30 minutes of exercise intervention or control, and then the second index test is performed immediately after exercise, recorded as Time 30. Both groups rested in place for 30 minutes, and the third index test was performed immediately after the rest, recorded as Time 60. The first experiment ended. After a week’s interval, the second experiment was conducted; except for the intervention methods for each group being crossed over, the other procedures were the same as in the first test. Both experiments were conducted in the laboratory of the Shandong Institute of Physical Education, and the experiments were started simultaneously. The experimental environment was kept quiet, ventilated and, at a suitable temperature. The duration of a single test was approximately 1 hour. | PMC10553036 | ||
2.6. Statistical analysis | PMC10553036 | |||
2.6.1. Descriptive statistics. | We used descriptive statistics for the baseline characteristics of the subjects, including the mean and standard deviation of age, sex ratio, height, weight, BMI, and age at play. | PMC10553036 | ||
2.6.2. Repeated measures ANOVA. | Statistical analysis was performed using statistical software SPSS 26.0 (IBM, Chicago, IL) and GraphPad Prism 9.0 software (GraphPad Software, San Diego, CA). The Shapiro–Wilk test was used to test the normal distribution of each continuous variable. Descriptive mean and standard deviation statistics were used for variables that followed a normal distribution, while the median and interquartile range were used for non-normally distributed data. A repeated measure two-way analysis of variance was used to determine the effects of exercise intervention and control on each outcome variable. | PMC10553036 | ||
2.6.3. Multiple comparison correction. | A Bonferroni-adjusted post hoc analysis was conducted when time-group interaction was detected. The effect size of the main effect and interaction was expressed using partial eta squared (η | PMC10553036 |
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