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Study setting {9} | MUI | SECONDARY | In this single-center prospective, triple-blinded, two-group, randomized trial, 60 patients will be recruited and randomly assigned to one of the two groups to test the effect of a PECS II block with ropivacaine 0.5% on the postoperative opioid demand (see Consolidated Standards of Reporting Trials flow diagram (CONSOR... | PMC10476350 |
Eligibility criteria {10} | pain, Psychiatric disorders, myxoma, allergies, atrial septal defect | SYSTEMIC INFECTION, DIABETIC NEUROPATHY, CHRONIC RENAL DISEASE, MYXOMA, ALLERGIES, VALVULAR HEART DISEASE, CHRONIC PAIN SYNDROME | Adult patient with an American Society of Anesthesiologist (ASA) physical status I-III, aged 18–80 years, scheduled for elective minimal invasive cardiac surgery, e.g., mitral valve procedures, tricuspid valve procedures, myxoma resection, or atrial septal defect repair. All participants will undergo the usual standard... | PMC10476350 |
Who will take informed consent? {26a} | Every participant must give written consent before participating in the clinical trial.An investigator will provide and obtain the informed consent form. Therein, the investigator will thoroughly inform the participant in oral and written form in an understandable manner for the patient about the character, importance,... | PMC10476350 | ||
Additional consent provisions for collection and use of participant data and biological specimens {26b} | On the consent form, participants will be asked if they agree to the use of their data should they choose to withdraw from the trial. This includes their data being used for analysis as well as any future publications or presentations related to the study. Since this is a monocenter trial, the consent form will not inc... | PMC10476350 | ||
The explanation for the choice of comparators {6b} | Two groups will be included. The intervention group receives PCS II block with 30 ml of ropivacaine 5 mg/ml, while the control group receives a plane PECS II block with 30 ml of sodium chloride 0.9%. All other medical interventions will be identical. | PMC10476350 | ||
Intervention description {11a} | pain | After obtaining written informed consent, all patients will be taught to assess pain using the visual analog scale (VAS; 0–100 mm). According to institutional standards, patients will be fasted for 6 h for solids and 2 h for fluids and receive oral premedication with midazolam 0.05–0.1 mg /kg if requested.Before the ar... | PMC10476350 | |
Postoperative analgesia regimen | At the end of the surgical procedures, all patients will receive a bolus of piritramide 0.1–0.2 mg/kg and will be transferred to the postoperative ICU ward. Patients will be extubated when extubation criteria are reached (normothermic, fully awakened, spontaneously breathing, hemodynamically stable with moderate vasopr... | PMC10476350 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | hemodynamic impairment, CRF | CRF, COMPLICATIONS | We will exclude patients from participating in case of failure to detect the suitable anatomical structures for PECS II.After PECS II is performed, it is impossible to change the allocated intervention after administration. Subjects are free to leave the study at any time for any reason without consequences. Study disc... | PMC10476350 |
Strategies to improve adherence to interventions {11c} | To improve adherence to the study protocol, the follow-up visits for the study are planned simultaneously with the standard measurements for patients in the MICS program at the Medical University of Innsbruck. Participants do not need to adhere to specific tasks. To support faculty staff, a study nurse who reviews the ... | PMC10476350 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | There is no expected interaction between the drug under investigation and concomitant medical treatments. Local prescribing information and institutional guidelines should be followed as applicable. | PMC10476350 | ||
Provisions for post-trial care {30} | injury or death | The sponsor has insurance by the legal requirements in Austria. This insurance covers damage to research participants through injury or death caused by the study. The insurance applies to the damage that becomes apparent during the study. | PMC10476350 | |
Outcomes {12} | The primary outcome parameter is the overall opioid demand given as intravenous MME during the first 24 h after extubation.Secondary outcome variables are the interval until extubation, ICU discharge, data collected in the ICU, length of hospital stay, the VAS at 2, 4, 6, 12, and 24 h after extubation, and the Overall ... | PMC10476350 | ||
Participant timeline {13} | Demographic and baseline data such as age, weight, height, and ASA score are collected soon after informed consent is granted, usually the day before surgery. On the day of surgery, data that define the type of surgery and the type and size of central venous cannulation will be noted. Also, hemodynamic data such as art... | PMC10476350 | ||
Sample size {14} | The main hypothesis of this study is that the use of PECS II blockade in patients undergoing minimally invasive cardiac surgery reduces the overall opioid demand given as morphine milligram equivalents (MME) during the first 24 h after extubation. The sample size needed to test this hypothesis was based on four previou... | PMC10476350 | ||
Recruitment {15} | RECRUITMENT | The MICS program at the University Clinic of Cardiac Surgery, Medical University of Innsbruck, serves as the primary recruitment institution. | PMC10476350 | |
Assignment of interventions: allocation | PMC10476350 | |||
Sequence generation {16a} | The investigational medication (ropivacaine 0.5%) assigned to individual patients is determined by a randomized schedule with a 1:1 allocation ratio. | PMC10476350 | ||
Concealment mechanism {16b} | BLIND | The randomization process will be realized independently from the clinical investigators using opaque envelopes (fully blind randomization). For each participant enrolled in the study, one envelope will be opened by the nurse who prepares the study medication. Preparation will be performed in a separate room without th... | PMC10476350 | |
Implementation {16c} | The randomization list will be generated using well-established software (randomization.org) for the two groups (intervention group, placebo group). Upon the arrival of the patient in the operating theatre, a study nurse will open an opaque envelope which is labeled with the patient’s identification code and prepare th... | PMC10476350 | ||
Assignment of interventions: blinding | PMC10476350 | |||
Who will be blinded {17a} | This study is, per definition, triple-blinded as the participants, care providers, and investigators involved in the study procedure do not know the randomization arm. All study assessments will be performed in an observer-blinded fashion. | PMC10476350 | ||
Procedure for unblinding if needed {17b} | A patient identification code will replace patient identifying data. The randomization list and the codebook will be stored digitally and only accessible to study personnel. Unblinding is possible at all times after consultation with the principal investigator. | PMC10476350 | ||
Data collection and management | PMC10476350 | |||
Plans for assessment and collection of outcomes {18a} | CRF | CRF | All investigators will be trained within the initiation visit. Training topics cover Good Clinical Practice, the study protocol, and OBAS and VAS assessment execution.The patient’s demographical data will be registered soon after the patient’s informed consent. The PECS II block will be performed by experienced anesthe... | PMC10476350 |
Plans to promote participant retention and complete follow-up {18b} | After enrollment and randomization, the investigators will make every reasonable effort to follow the study subject throughout the entire study period. Subjects are free to discontinue their study participation at any time. Participant retention will be increased by implementing study visits into routine clinical posto... | PMC10476350 | ||
Data management {19} | CRF | CRF | An independent internal monitor (Tirol Kliniken) will provide the monitoring and quality assurance of the study. The study team will process data entry from paper based CRF into statistical software. Programmed checks make data validation of range, validity, and consistency. If necessary, queries are made by the study ... | PMC10476350 |
Confidentiality {27} | All local legal requirements regarding data protection will be adhered to. All study findings and documents will be regarded as confidential. The Investigator and research team members must not disclose any information without prior written approval from the Sponsor.The pseudonymity of patients participating must be ma... | PMC10476350 | ||
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | Not applicable; no biological specimens will be collected for this study. | PMC10476350 | ||
Statistical methods | PMC10476350 | |||
Statistical methods for primary and secondary outcomes {20a} | Data will be entered into electronic case record files (eCRF; RedCap®, Nashville, TN). R 4.2 (The R Project for Statistical Computing, Vienna, Austria) will be used for statistical analysis. The normality of data will be assessed using graphical and inferential tests. Median/interquartile range or mean/standard deviati... | PMC10476350 | ||
Interim analyses {21b} | This study can be classified as low risk; no interim analyses will be conducted during this trial. | PMC10476350 | ||
Methods for additional analyses (e.g., subgroup analyses) {20b} | No subgroup analysis is planned, justified by the sample size and the pragmatic study design.We anticipated that there would be meaningful differences in treatment effects across subgroups of participants. | PMC10476350 | ||
Sample size | Our study was designed to detect an effect of the PECS II block on 24 h postoperative opioid demand. As patients undergoing minimal invasive mitral valve surgery tend to be quite a homogenous population, to our understanding, conducting subgroup analyses would not have added much value to our study. Also, conducting su... | PMC10476350 | ||
Methods in analysis to handle protocol non-adherence and any statistical forms to handle missing data {20c} | PMC10476350 | |||
Per-protocol population | bleeding | BLEEDING, HEMODYNAMIC INSTABILITY, COMPLICATIONS, SECONDARY | The per-protocol-population will include all patients who received intervention or sham intervention (placebo) and surgery without major protocol deviations. Significant protocol deviations or complications (hemodynamic instability, prolonged intubation, reintubation, bleeding, reoperation) and subsequent failure to ob... | PMC10476350 |
Intention-to-treat population | The intention-to-treat population will consist of all patients who were enrolled in the study and gave informed consent, but data is missing due to the abovementioned factors. This population will be analyzed in a separate ITT cohort. In case of withdrawals and missing data, the last observation carried forward (LOCF) ... | PMC10476350 | ||
Plans to give access to the complete protocol, participant-level data, and statistical code {31c} | The entire protocol of the study will be published together with a manuscript on the clinical trial results. The datasets analyzed during the current study and the statistical code will be available from the corresponding author upon reasonable request. It will only be accessible to personnel directly involved in the s... | PMC10476350 | ||
Oversight and monitoring | PMC10476350 | |||
Composition of the coordinating center and trial steering committee {5d} | This is an investigator-initiated, single-center trial, run by a small study team that can be seen as the trial steering committee. Organizational support will be provided by the Competence Centre for Clinical Trials, Medical University of Innsbruck (KKS). The study team meets on a daily basis, to review routine clinic... | PMC10476350 | ||
Composition of the data monitoring committee, its role and reporting structure {21a} | An independent local monitor (Tirol Kliniken) will check trial quality repeatedly (at least every 6 months) and check at least 10% of the signed informed consent files (ICF). Complete data of the first five participants will be reviewed, including inclusion and exclusion criteria. The study has a low risk; therefore, t... | PMC10476350 | ||
Adverse event reporting and harms {22} | ADVERSE EVENTS, ADVERSE EVENT | Although serious adverse events are not to be expected, the sponsor and the principal investigator will suspend the study if there is reasonable doubt that the continuation of the survey will compromise the safety and well-being of participants. In this case, the local ethics committee will be informed immediately, and... | PMC10476350 | |
Frequency and plans for auditing trial conduct {23} | CRF | CRF | For quality assurance, monitoring audits will be performed. An independent local monitor will perform the monitoring.Monitoring visits will be conducted to review study plan compliance, compare CRFs and individual patients’ medical records, perform an accounting of study material, and ensure that the study is conducted... | PMC10476350 |
Plans for communicating significant protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | After the protocol has been submitted to the ethics committee (EC), any substantial change will require a formal amendment. The amendment must be signed by all of the signatories to the original protocol. Once the study has started, amendments should be made only in exceptional cases. The ethics committees must be info... | PMC10476350 | ||
Dissemination plans {31a} | For all publications, the data protection of the subjects will be maintained. This includes a presentation at national and international conferences and publications in scientific journals. The study data are the property of the Medical University of Innsbruck. The data from the whole trial can be published separately.... | PMC10476350 | ||
Discussion | Acute postoperative pain, pectoral muscle resection | CHRONIC PAIN, SECONDARY | This study will assess the opioid demand during the first 24 h after extubation following MICS. The available evidence on using local anesthetics in major cardiac surgery is scarce [The secondary endpoints assess the evolution of VAS during the first 24 h, namely 2, 4, 6, 8, 12, and 24 h after extubation. Also, the OBA... | PMC10476350 |
Trial status | Protocol version 1.4, effective date: 21 January 2022. First patient first visit (FPFV): 08 February 2022. Currently, 36 of 50 participants are included, date: 11 October 2022. Last patient last visit (LPLV) is expected in April 2023. | PMC10476350 | ||
Acknowledgements | Not applicable. | PMC10476350 | ||
Authors’ contributions {31b} | NB | EH: Conception and design of the study, study investigation, drafting the article, final approval. OS: Conception and design of the study, study investigation, drafting the article, final approval. FN: Study investigation, drafting the article, final approval. AF: Study investigation, drafting the article, final approv... | PMC10476350 | |
Funding {4} | The PECS MICS trial is investigator-initiated at the Medical University of Innsbruck, Austria. | PMC10476350 | ||
Availability of data and materials {29} | The datasets analyzed during the current study are available from the principal investigator or the corresponding author on reasonable request and are otherwise only accessible to the study collaborators. | PMC10476350 | ||
Declarations | PMC10476350 | |||
Ethics approval and consent to participate {24} | der Medizinischen Universität Innsbruck-Austria | This trial was approved by the local ethical committee (Ethiokkommission der Medizinischen Universität Innsbruck-Austria) (EK Nr:1332/2022, date 17 January 2022) from the local Ethical Committee (Ethiokkommission der Medizinischen Universität Innsbruck-Austria). | PMC10476350 | |
Consent for publication {32} | Not applicable. | PMC10476350 | ||
Competing interests {28} | The authors declare no competing interests. | PMC10476350 | ||
References | PMC10476350 | |||
Subject terms | RPE | This study investigates the effect of the consumption of caffeinated chewing gum on the performance of Romanian deadlift on the flywheel training device. A total of 19 participants completed a randomized, cross-over, single-blind experiment with food-grade caffeinated chewing gum trial (CAF) or placebo trail (PL). Gum ... | PMC10716112 | |
Introduction | In recent years, resistance training has become increasingly popular. Training methods typically involve lifting some sort of weight, such as barbells, dumbbells, and pulleys. This type of training focuses primarily on counteracting the force of gravity. In contrast, flywheel training, also known as inertial training, ... | PMC10716112 | ||
Materials and methods | PMC10716112 | |||
Experimental design | SECONDARY | The study was a randomized, crossover, single-blind study design in which participants were randomized to ingest a caffeinated chewing gum trial (CAF) and a placebo gum trial (PL) 7 days apart, 10 min before performing the Romanian deadlift on a flywheel training device, CONSORT diagram and study design as shown in Fig... | PMC10716112 | |
Participants | All 19 participants (age 22.5 (3.5) years; height 176.2 (6.5) cm; body mass 78.8 (13.2) kg; habitual caffeine intake: 62.55 (94.01) mg/day). A priori power analysis, using an expected effect size (f) of 0.55 for peak eccentric power on the Romanian deadlift test, an α of 0.05, a statistical power of 0.80All participant... | PMC10716112 | ||
Experimental protocol | Experimental protocol was shown on Fig. Experimental protocol.On the day before the first formal experiment, the participants' dietary intake was recorded, and they were asked to replicate the same diet before the next experiment. Participants were also instructed to avoid consuming caffeinated foods for 24 h before th... | PMC10716112 | ||
Statistical analysis | RPE | The Shapiro–Wilk test was conducted to test the normality of the data. Two-way ANOVA was used to compare the differences in heart rate, RPE and other measures between the CAF trial and the PL trial before and after the Romanian deadlift inertia resistance training test. We represent standard deviations in parentheses [... | PMC10716112 | |
Ethics approval and consent to participate | This study was approved by the Institutional Review Board of Jen-Ai Hospital (111-09) in Taiwan. | PMC10716112 | ||
Results | All 19 participants completed the test sessions and were included in the analysis. According to the pre-test dietary questionnaire, the participants had an average daily caffeine intake of 62.55 (94.01) mg. The absolute dose of caffeine given in this experiment was 200 mg, and after weight calculation, the caffeine int... | PMC10716112 | ||
Discussion | RPE | The main findings of this study were that caffeine ingestion via caffeinated chewing gum significantly improved the performance of the Romanian deadlift on the flywheel exercise compared to placebo in peak concentric power, peak eccentric power, average power and total work. However, there were no significant differenc... | PMC10716112 | |
Strength and limitations | This trial used a rigorous two-arm crossover randomized controlled design. All outcomes were measured by Exxentric kMeter (© Exxentric AB, Sweden) to ensure reliabilityThis study provides new evidence on the potential benefits of using caffeinated chewing gum to enhance physical performance. However, it is important to... | PMC10716112 | ||
Acknowledgements | Thanks for National Taiwan University of Sport, National Science and Technology Council and China medical university hospital to provide the equipment and necessary assistance for this study. | PMC10716112 | ||
Author contributions | S.-H.W. | C.-C.H. and S.-H.W. assisted the data analysis and manuscript preparation. Y.-C.H., S.-Y.Y. assisted the experimental design and manuscript preparation. C.-H.C. carried out the experiment, data analysis and assisted the manuscript preparation. | PMC10716112 | |
Funding | This study was not funded by any organization. The publication fees were funded by China medical university hospital. | PMC10716112 | ||
Data availability | All relevant materials are presented in the present manuscript. | PMC10716112 | ||
Competing interests | The authors declare no competing interests. | PMC10716112 | ||
References | PMC10716112 | |||
Introduction | adrenal tumors, prednisoloneEndothelial dysfunction, adrenal incidentalomas, hypertension, benign nonfunctioning adrenal adenomas, Adrenal incidentalomas | ADRENAL INCIDENTALOMA, ADRENAL TUMORS, EVENTS, ATHEROSCLEROSIS, HYPERTENSION, PATHOGENESIS, ADRENAL INCIDENTALOMAS | Adrenal incidentalomas are adrenal tumors that are detected unexpectedly during imaging procedures conducted for unrelated reasons. Most of the adrenal incidentalomas are classified as benign nonfunctioning adrenal adenomas (NFA), and patients with NFA which have lower rates of cardiovascular events and mortality than ... | PMC10684497 |
Results | PMC10684497 | |||
Study protocol 1 | PMC10684497 | |||
Baseline clinical characteristics | hypertension | HYPERTENSION | The baseline clinical characteristics of the 272 control patients with hypertension and/or DM and 22 patients with NFA who had hypertension and/or DM are summarized in Supplemental Table Moreover, we assessed vascular function in patients with NFA who had hypertension and/or DM using propensity score matching to create... | PMC10684497 |
Vascular function in patients without adrenal incidentalomas and patients with NFA | hypertension | HYPERTENSION | There were no significant differences in FMD and NID between control patients with hypertension and/or DM and patients with NFA who had hypertension and/or DM (3.4 ± 2.8% vs. 2.9 ± 1.9% and 11.5 ± 5.7% vs. 11.4 ± 4.3%, P = 0.46, and P = 0.99, respectively) (Supplemental Table In propensity score-matched pairs of contro... | PMC10684497 |
Study protocol 2 | PMC10684497 | |||
Baseline clinical characteristics | The baseline clinical characteristics of the 320 control patients and 18 patients with NFA are summarized in Supplemental Table Moreover, we assessed vascular function in patients with NFA using propensity score matching to create matched pairs between control patients and patients with NFA. In propensity score-matched... | PMC10684497 | ||
Discussion | DM, hypertension, cerebral infarct, Cushing’s syndrome | VASODILATION, HYPERTENSION, CEREBRAL INFARCT | In the present study, we demonstrated that there were no significant differences in FMD and NID between control patients with hypertension and/or DM and patients with NFA who had hypertension and/or DM even after adjustment for cardiovascular risk factors. Overnight 1 mg dexamethasone increased FMD and NID in patients ... | PMC10684497 |
Conclusions | hypertension | HYPERTENSION | There were no significant differences in vascular function between control patients with hypertension and/or DM and patients with NFA who had hypertension and/or DM even after adjustment for cardiovascular risk factors. In patients with NFA, administration of overnight 1 mg dexamethasone is associated with increases in... | PMC10684497 |
Methods | PMC10684497 | |||
Study protocol 1: vascular function in patients without adrenal incidentalomas and patients with NFA | cancer, Cushing’s syndrome, adrenal incidentalomas, Hypertension, hypertensive, nonfunctioning adrenal incidentalomas, hypertension | ADRENAL INCIDENTALOMA, CANCER, RENAL DISEASE, HYPERTENSION, HYPERTENSION, SECONDARY HYPERTENSION | This study was a single-center and prospective cohort study. Between August 2007 and August 2022, a total of 2657 subjects were recruited for vascular function measurements from individuals who attended the outpatient clinic at Hiroshima University Hospital. Of the 2657 subjects, 1105 subjects without computed tomograp... | PMC10684497 |
Study protocol 2: impacts of overnight 1 mg dexamethasone on vascular function in patients with NFA | adrenal incidentalomas, Cushing’s syndrome | PRIMARY ALDOSTERONISM, ADRENAL INCIDENTALOMA | Between November 2020 and August 2022, a total of 28 consecutive patients with adrenal incidentalomas were recruited for vascular function measurements from patients who attended the outpatient clinic at Hiroshima University Hospital. Ten of the 28 patients with adrenal incidentalomas, including five patients with subc... | PMC10684497 |
Measurements of FMD and NID | artery transducer | VASODILATION, REACTIVE HYPEREMIA | FMD was measured in vascular response to reactive hyperemia in the brachial artery as endothelium-dependent vasodilation. A high-resolution linear artery transducer was coupled to computer-assisted analysis software (UNEXEF18G, UNEX Co, Nagoya, Japan) that used an automated edge detection system for measurement of brac... | PMC10684497 |
Statistical analysis | DM, adrenal incidentalomas, hypertension | ADRENAL INCIDENTALOMA, CORONARY HEART DISEASE, REGRESSION, HYPERTENSION, DYSLIPIDEMIA | Results are summarized as means ± SD for continuous variables and percentages for categorical variables. Statistical significance was a probability value of < 0.05. The comparison of continuous variables was conducted using ANOVA with Tukey’s post hoc test. The comparison of categorical variables between groups was con... | PMC10684497 |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-48295-y. | PMC10684497 | ||
Acknowledgements | We thank Megumi Wakisaka, Ki-ichiro Kawano, and Satoko Michiyama for their excellent secretarial assistance. | PMC10684497 | ||
Author contributions | S.K. and Y.H. contributed to the study design. S.K., T.M., M.K., A.M., T.Y., T.H., Y.N, C.G., F.M.Y., and A.N. performed the data collection. S.K. performed statistical analyses after discussion with all authors. S.K., Y.H. contributed to the writing of the manuscript. Y.N. revised the article critically for important ... | PMC10684497 | ||
Funding | This study was supported in part by a Grant-in-Aid for Scientific Research from the Ministry of Education, Science, and Culture of Japan (18590815 and 21590898 to Higashi). | PMC10684497 | ||
Data availability | The data presented in this study are available on request from the corresponding author. | PMC10684497 | ||
Competing interests | The authors declare no competing interests. | PMC10684497 | ||
References | PMC10684497 | |||
Key Points | PMC10485729 | |||
Question | Does cognitive training for working memory in children born very preterm improve visuospatial processing? | PMC10485729 | ||
Findings | In this multicenter, open label randomized clinical trial of 169 children aged 5½ to 6 years who were born very preterm, a cognitive training program showed no long-term efficacy for visuospatial processing. | PMC10485729 | ||
Meaning | memory disorders | The study found that a cognitive training program had no benefit for improving visuospatial processing among children born very preterm who had working memory disorders. | PMC10485729 | |
Importance | term-born | Compared with term-born peers, children born very preterm generally perform poorly in executive functions, particularly in working memory and inhibition. By taking advantage of neuroplasticity, computerized cognitive training of working memory in those children could improve visuospatial processing by boosting visual i... | PMC10485729 | |
Objective | cognitive working memory, memory impairment | To evaluate the long-term effect of cognitive working memory training on visuospatial processing in children aged 5½ to 6 years born very preterm who have working memory impairment. | PMC10485729 | |
Design, Setting, and Participants | This multicenter (18 French university hospitals), open-label randomized clinical trial with 2 parallel groups (EPIREMED) was conducted from November 2016 to April 2018, with the last follow-up during August 2019. Eligible children from the EPIPAGE 2 cohort were aged 5½ to 6 years, were born between 24 and 34 weeks’ ge... | PMC10485729 |
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