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Findings | In this pragmatic randomized clinical trial including 287 patients at 19 sites in 3 countries, the rate unfavorable neurologic outcome was 32.6% in the lumbar drainage group (47 of 144) and 44.8% in the standard of care group (64 of 143), a significant difference. | PMC10277935 | ||
Meaning | aneurysmal subarachnoid hemorrhage, lumbar cerebrospinal fluid | In this trial, among patients with aneurysmal subarachnoid hemorrhage, lumbar drainage improved clinical neurological outcomes at 6 months.This pragmatic randomized clinical trial evaluates the effectiveness of early lumbar cerebrospinal fluid drainage added to standard of care in patients after aneurysmal subarachnoid... | PMC10277935 | |
Importance | aneurysmal subarachnoid hemorrhage | DELAYED CEREBRAL ISCHEMIA | After aneurysmal subarachnoid hemorrhage, the use of lumbar drains has been suggested to decrease the incidence of delayed cerebral ischemia and improve long-term outcome. | PMC10277935 |
Objective | lumbar cerebrospinal fluid, aneurysmal subarachnoid hemorrhage | To determine the effectiveness of early lumbar cerebrospinal fluid drainage added to standard of care in patients after aneurysmal subarachnoid hemorrhage. | PMC10277935 | |
Design, Setting, and Participants | acute aneurysmal subarachnoid hemorrhage, Aneurysm | ANEURYSM | The EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation conducted at 19 centers in Germany, Switzerland, and Canada. The first patient entered January 31, 2011, and the last on January 24, 2016, after 307 randomizations. Follow-up was com... | PMC10277935 |
Intervention | Early lumbar drainage, aneurysm | SUBARACHNOID HEMORRHAGE, ANEURYSM | A total of 144 patients were randomized to receive an additional lumbar drain after aneurysm treatment and 143 patients to standard of care only. Early lumbar drainage with 5 mL per hour was started within 72 hours of the subarachnoid hemorrhage. | PMC10277935 |
Main Outcomes and Measures | hemorrhage | HEMORRHAGE | Primary outcome was the rate of unfavorable outcome, defined as modified Rankin Scale score of 3 to 6 (range, 0 to 6), obtained by masked assessors 6 months after hemorrhage. | PMC10277935 |
Results | aneurysmal subarachnoid hemorrhage | Of 287 included patients, 197 (68.6%) were female, and the median (IQR) age was 55 (48-63) years. Lumbar drainage started at a median (IQR) of day 2 (1-2) after aneurysmal subarachnoid hemorrhage. At 6 months, 47 patients (32.6%) in the lumbar drain group and 64 patients (44.8%) in the standard of care group had an unf... | PMC10277935 | |
Conclusion and Relevance | aneurysmal subarachnoid hemorrhage, infarction | SECONDARY, INFARCTION | In this trial, prophylactic lumbar drainage after aneurysmal subarachnoid hemorrhage lessened the burden of secondary infarction and decreased the rate of unfavorable outcome at 6 months. These findings support the use of lumbar drains after aneurysmal subarachnoid hemorrhage. | PMC10277935 |
Trial Registration | ClinicalTrials.gov Identifier: | PMC10277935 | ||
Introduction | death, intracranial aneurysm, a ruptured cerebral aneurysm, stroke, Subarachnoid hemorrhage, permanent disability, hemorrhage, rupture, culprit aneurysm | INTRACRANIAL ANEURYSM, STROKE, SUBARACHNOID HEMORRHAGE, HEMORRHAGE, SUBARACHNOID HEMORRHAGE, RUPTURED CEREBRAL ANEURYSM | Subarachnoid hemorrhage from the rupture of an intracranial aneurysm is a type of stroke leading to death or permanent disability in most affected patients.It is common standard to occlude the culprit aneurysm by surgical clipping or endovascular coiling within 24 to 48 hours after hemorrhage, with coiling being prefer... | PMC10277935 |
Methods | PMC10277935 | |||
Trial Design and Oversight | subarachnoid hemorrhage, aneurysm | SUBARACHNOID HEMORRHAGE, ANEURYSM | The EARLYDRAIN trial was a pragmatic, multicenter, parallel-group, open-label randomized clinical trial with blinded end point evaluation performed in 19 hospitals in Germany, Switzerland, and Canada. Trial sites were referral centers that provided acute neurosurgical and neurocritical care for patients with subarachno... | PMC10277935 |
Participants | intracranial aneurysm, aneurysmal, Aneurysm, hemorrhage, acute subarachnoid hemorrhage | ANEURYSM, HEMORRHAGE, SUBARACHNOID HEMORRHAGE, INTRACRANIAL ANEURYSM | To be eligible, patients had to be 18 years or older and present with acute subarachnoid hemorrhage diagnosed by computed tomography (CT) and confirmation of an intracranial aneurysm by CT angiography or digital subtraction angiography. Aneurysm treatment was required to be performed within 48 hours after subarachnoid ... | PMC10277935 |
Randomization | Eligible patients were randomized in a 1:1 ratio to receive either standard of care or the additional use of a lumbar drain. Randomization was performed via an internet randomizer. | PMC10277935 | ||
Data Collection | death | RECRUITMENT | Patients included in the EARLYDRAIN trial were followed up to their death or 6 months after randomization. Primary documentation was paper based and entered centrally in a database after finishing the recruitment phase. We collected baseline demographic and processes-of-care data from the first 8 days, descriptive radi... | PMC10277935 |
Trial Procedures | vasospasm, aneurysm, angioplasty | ANEURYSM, VASOSPASM, STERILE, SUBARACHNOID HEMORRHAGE, EMERGENCY | Emergency treatment on admission using intubation and/or placement of an external ventricular drain was at the discretion of the local team. We performed aneurysm treatment with coiling or clipping, as applicable and per local standard and in concordance with international guidelines and recommendations.In case of rand... | PMC10277935 |
Primary and Secondary End Points | subarachnoid hemorrhage, aneurysm, infarctions | SUBARACHNOID HEMORRHAGE, ANEURYSM, SECONDARY | Primary end point was the rate of unfavorable neurological outcome at 6 months after subarachnoid hemorrhage measured with the mRS.The main secondary end point was the rate of secondary infarctions not being present in the postprocedural CT scan performed after aneurysm occlusion. Secondary infarctions were diagnosed w... | PMC10277935 |
Statistical Analysis | REGRESSION, SECONDARY | For sample size calculation in the study planning phase, available retrospective studies were of questionable external validity due to their exceptionally low mortality. Data from the prospective LUMAS trial were not yet available.All statistics were performed with R version 4.1.0 (The R Foundation). Missing data were ... | PMC10277935 | |
Results | PMC10277935 | |||
Patient Characteristics | RECRUITMENT | The first patient was enrolled January 31, 2011. After 300 randomizations, 7 allocation failures were known, and the data monitoring and safety board decided to replace these. On January 24, 2016, recruitment in the EARLYDRAIN trial finished after 307 randomizations. A total of 152 randomizations indicated standard of ... | PMC10277935 | |
CONSORT Diagram | Patients were screened by acute care clinicians from the affiliated centers, mainly the departments of neurology and neurosurgery. Numbers of screened patients were not recorded in all affiliated hospitals (eTable 2 in Of 287 included patients, 197 (68.6%) were female, and the median (IQR) age was 55 (48-63) years. A t... | PMC10277935 | ||
Baseline Characteristics of Patients Recruited for the EARLYDRAIN trial (Intention-To-Treat Data) | aneurysm, fever, Aneurysm, vasospasm, subarachnoid hemorrhage | ANEURYSM, SUBARACHNOID HEMORRHAGE, VASOSPASM, ANEURYSM | Abbreviations: ACA, anterior cerebral artery; ACoA, anterior communicating artery; BA, basilar artery; ICA, internal carotid artery; MCA, middle cerebral artery; PCoA, posterior communicating artery; VA, vertebral artery; WFNS, World Federations of Neurosurgical Societies.Hunt-Hess and WFNS (World Federations of Neuros... | PMC10277935 |
Analysis of Primary and Secondary Outcomes | death, aneurysm occlusion | INTRAVENTRICULAR HEMORRHAGE | Abbreviations: GOS-E, Glasgow Outcome Scale–Extended; mRS, modified Rankin Scale score; NA, not applicable; VP, ventriculoperitoneal.Adjustment for baseline imbalances performed with the parameters of age, Hunt-Hess grade greater than 3, and intracerebral or intraventricular hemorrhage.No transcranial Doppler was perfo... | PMC10277935 |
Primary End Point | No patient was lost for evaluation of the primary end point. In the intention-to-treat analysis, 47 of 144 patients (32.6%) in the lumbar drain group and 64 of 143 patients (44.8%) in the standard of care group had an unfavorable outcome at 6 months (unadjusted relative risk, 0.73; 95% CI, 0.51-0.98; absolute risk diff... | PMC10277935 | ||
Scores on the Modified Rankin Scale (mRS) at 6 Months, Intention-to-Treat Data | subarachnoid hemorrhage, death, disability | MINOR, SUBARACHNOID HEMORRHAGE | Patients in the lumbar drain group received standard of care and additional lumbar drain at a planned rate of 5-mL lumbar cerebrospinal fluid diversion in the first 8 days. Patients in the standard of care group received standard of care subarachnoid hemorrhage treatment alone. Scores on the mRS range from 0 to 6, with... | PMC10277935 |
Secondary End Points | infarction | SECONDARY, INFARCTION | A total of 41 patients (28.5%) in the lumbar drain group and 57 patients (39.9%) in the standard of care group experienced a secondary infarction seen on the last cerebral imaging scan before discharge (unadjusted relative risk, 0.71; 95% CI, 0.49-0.99; absolute risk difference, −0.11; 95% CI, −0.22 to 0; | PMC10277935 |
Subgroup Analysis | The effect of lumbar drains on the primary outcome was consistent across prespecified subgroups ( | PMC10277935 | ||
Subgroup Analysis | death, subarachnoid hemorrhage, high-grade functional disability | SUBARACHNOID HEMORRHAGE | The forest plot shows that the relative risk of moderate-grade to high-grade functional disability or death favors treatment with a lumbar drain additional to standard of care across all prespecified subgroups. Hunt-Hess and World Federations of Neurosurgical Societies (WFNS) scales are severity gradings scales, with 1... | PMC10277935 |
Per-Protocol and As-Treated Sensitivity Analysis | infarctions | INTRAVENTRICULAR HEMORRHAGE | End points for sensitivity analysis were the rate of infarctions at discharge and long-term unfavorable outcome. Analyses were performed unadjusted and adjusted for baseline imbalances in age, Hunt-Hess grade, and intraparenchymal and intraventricular hemorrhages. All outcomes in sensitivity analyses were in favor of t... | PMC10277935 |
Adverse Events | infections, skin infection | INFECTIONS, SKIN INFECTION | One patient was reported to develop an increasing gradient of more than 5 mm Hg in ICP readings from the external ventricular drain and the lumbar drain, prohibiting continuation of lumbar drainage. One patient developed a local skin infection at the entrance of the lumbar drain requiring surgical excision. In 1 patien... | PMC10277935 |
Post Hoc Analysis | Infarctions, infarctions, Vasospasm | INFARCTIONS, VASOSPASM | Vasospasm, detected by clinical means, transcranial Doppler, or with angiography, was associated with the rate of infarctions at discharge. Infarctions at discharge were associated with unfavorable outcome at 6 months (eTables 4-9 in | PMC10277935 |
Discussion | pneumonia, fever, traumatic brain injury, brain edema, obstructive hydrocephalus, vasospasm, infarctions, Infarct, aneurysmal subarachnoid hemorrhage, Vasospasm | DELAYED CEREBRAL ISCHEMIA, PNEUMONIA, BRAIN EDEMA, OBSTRUCTIVE HYDROCEPHALUS, DEPOLARIZATION, CNS INFECTIONS, VASOSPASM, DISEASE, SECONDARY, INFARCT, VASOSPASM | In the EARLYDRAIN trial involving patients with aneurysmal subarachnoid hemorrhage of all grades, the use of a lumbar drain in addition to standard of care resulted in less infarctions at discharge and decreased the rate of unfavorable outcome at 6 months. The amount of cerebrospinal fluid drained in the first week was... | PMC10277935 |
Limitations | hypertension | CLOTS, CLOT, SUBARACHNOID HEMORRHAGE, MEDICAL COMPLICATION, HYPERTENSION | This trial has several limitations. First, we were unable to secure sufficient funding to allow timely completion of the EARLYDRAIN trial, prohibiting hiring of dedicated personnel.A significant number of patients in the lumbar drain group did not receive the allocated intervention for various reasons. Crossover patien... | PMC10277935 |
Conclusion | aneurysmal subarachnoid hemorrhage, lumbar cerebrospinal fluid, infarction | INFARCTION | In patients with aneurysmal subarachnoid hemorrhage, prophylactic lumbar cerebrospinal fluid drainage is warranted to lessen the burden of infarction at discharge and reduce the rate of unfavorable outcome at 6 months. Our findings support the use of a lumbar drain additional to standard of care. | PMC10277935 |
Abstract | PMC10511620 | |||
Background | TG, gastric cancer | GASTRIC CANCER | Distal gastrectomy (DG) for gastric cancer can cause less morbidity than total gastrectomy (TG), but may compromise radicality. No prospective studies administered neoadjuvant chemotherapy, and few assessed quality of life (QoL). | PMC10511620 |
Methods | tumors, TG | POSTOPERATIVE COMPLICATION, SECONDARY, TUMORS, GASTRIC ADENOCARCINOMA | The multicenter LOGICA-trial randomized laparoscopic versus open D2-gastrectomy for resectable gastric adenocarcinoma (cT1–4aN0–3bM0) in 10 Dutch hospitals. This secondary LOGICA-analysis compared surgical and oncological outcomes after DG versus TG. DG was performed for non-proximal tumors if R0-resection was deemed a... | PMC10511620 |
Results | Between 2015 and 2018, 211 patients underwent DG ( | PMC10511620 | ||
Conclusions | TG | COMPLICATIONS | If oncologically feasible, DG should be preferred over TG due to less complications, faster postoperative recovery, and better QoL while achieving equivalent oncological effectiveness. | PMC10511620 |
Mini-abstract | gastric cancer | COMPLICATIONS, GASTRIC CANCER | Distal D2-gastrectomy for gastric cancer resulted in less complications, shorter hospitalization, quicker recovery and better quality of life compared to total D2-gastrectomy, whereas radicality, nodal yield and survival were similar. | PMC10511620 |
Supplementary Information | The online version contains supplementary material available at 10.1007/s11605-023-05683-z. | PMC10511620 | ||
Keywords | PMC10511620 | |||
Introduction | Gastric cancer, TG, gastric cancer | GASTRIC CANCER, DISEASE, GASTRIC CANCER | Gastric cancer is the third leading cause of cancer-related mortality worldwide.Although both DG and TG are safe to perform, previous studies exposed several differences and concerns regarding their associated surgical and oncological outcomes.However, no prospective studies compared outcomes after neoadjuvant chemothe... | PMC10511620 |
Methods | PMC10511620 | |||
Study Design | TG | SECONDARY, GASTRIC ADENOCARCINOMA | This study is a secondary analysis in the prospective, multicenter LOGICA-trial to compare surgical and oncological outcomes including QoL after DG versus TG for resectable gastric adenocarcinoma (cT1–4aN0–3bM0) in 10 Dutch hospitals. The randomized controlled LOGICA-trial (NCT02248519) compared laparoscopic versus ope... | PMC10511620 |
Patient Selection and Randomization | The inclusion and exclusion criteria were listed in the LOGICA protocol. | PMC10511620 | ||
Staging and Treatment | tumor, tumors, TG | TUMOR, TUMORS, GASTRIC CANCER | Regional multidisciplinary tumor boards determined the staging and individual treatment strategy according to Dutch national guidelines, which is elaborated in the LOGICA-protocol.Consecutively, DG was performed for distal (pylorus, antrum) and middle (distal corpus) gastric cancer, whereas tumors located in the gastri... | PMC10511620 |
Surgeon Experience and Quality Control | ONCOLOGY | Prior to the trial start, all surgeons completed the European Society for Surgical Oncology (ESSO) Training Program on Minimally Invasive Gastrectomy and at least two laparoscopic gastrectomies per surgeon were centrally reviewed by study proctors (RvH and JR).The LOGICA-trial included a mandatory surgical quality cont... | PMC10511620 | |
Outcome Measures | pneumonia, pancreatic injury, blood loss, abscess, TG, ileus | PNEUMONIA, BLOOD LOSS, WOUND INFECTION, POSTOPERATIVE COMPLICATION, ABSCESS, LEAKAGE, ATRIAL FIBRILLATION, COMPLICATIONS, ILEUS | The main outcome was overall postoperative complication rate after DG versus TG. In addition, both groups were compared regarding individual complications (i.e., anastomotic leakage, pneumonia, atrial fibrillation, ileus, abscess, pancreatic injury, chyle leakage, wound infection), mortality, oncological outcomes (e.g.... | PMC10511620 |
Statistical Analysis | Outcomes were compared using the (independent sample) unpaired | PMC10511620 | ||
Discussion | tumor, pneumonia, blood loss, tumors, TG, gastric cancer | TUMOR, PNEUMONIA, POSTOPERATIVE COMPLICATIONS, BLOOD LOSS, MINOR, LEAKAGE, ATRIAL FIBRILLATION, TUMORS, COMPLICATIONS, GASTRIC CANCER | This study aimed to determine the role of DG for Western gastric cancer patients by comparing surgical and oncological outcomes including quality of life after DG versus TG, in particular in a population where the vast majority of patients was treated with neoadjuvant chemotherapy. Patients selected to undergo DG exper... | PMC10511620 |
Funding | The LOGICA-trial (NCT02248519) was funded by ZonMw (The Netherlands Organization for Health Research and Development), project number 837002502. | PMC10511620 | ||
Data Availability | Prof. dr. R. van Hillegersberf had full access to all trial data. The data are not publicly available for privacy reasons, and may be provided upon reasonable request. | PMC10511620 | ||
Declarations | PMC10511620 | |||
Disclosures | Richard van Hillegersberg: consulting or advisory role: intuitive surgical, Medtronic. Jelle Ruurda: consulting or advisory role: intuitive surgical. Lodewijk Brosens: advisory role: Bristol Myers Squibb. Grard Nieuwenhuijzen: consulting or advisory role: Medtronic. The other authors have no disclosures. All authors de... | PMC10511620 | ||
References | PMC10511620 | |||
Background | prostate cancer, prostate | PROSTATE CANCER, PROSTATE | This study aimed to explore the value of combined serum lipids with clinical symptoms to diagnose prostate cancer (PCa), and to develop and validate a Nomogram and prediction model to better select patients at risk of PCa for prostate biopsy. | PMC10349516 |
Methods | TG, prostate | REGRESSION, PROSTATE | Retrospective analysis of 548 patients who underwent prostate biopsies as a result of high serum prostate-specific antigen (PSA) levels or irregular digital rectal examinations (DRE) was conducted. The enrolled patients were randomly assigned to the training groups (n = 384, 70%) and validation groups (n = 164, 30%). T... | PMC10349516 |
Results | TG, prostate cancer | REGRESSION, PROSTATE CANCER | 210 (54.70%) of the patients in the training group were diagnosed with PCa. Multivariate regression analysis showed that total PSA, f/tPSA, PSA density (PSAD), TG, LDL, DRE, and TRUS were independent risk predictors of PCa. A prediction model utilizing a Nomogram was constructed with a cut-off value of 0.502. The train... | PMC10349516 |
Conclusions | PROSTATE CANCER | The prediction model and Nomogram, which utilize both blood lipid levels and clinical signs, demonstrated improved accuracy in predicting the risk of prostate cancer, and consequently can guide the selection of appropriate diagnostic strategies for each patient in a more personalized manner. | PMC10349516 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12894-023-01291-w. | PMC10349516 | ||
Keywords | PMC10349516 | |||
Introduction | cancer, prostate, Prostate cancer, high-density lipoprotein, TG, prostate cancer | CANCER, PROSTATE CANCER, PROSTATE CANCER, PROSTATE | Prostate cancer (PCa) remains the most common cause of cancer-related mortality among men worldwide, and they were rapidly increasing in Asia as well [In clinical practice, prostate biopsy has long been recognized as the most reliable method for identifying and diagnosing prostate cancer, earning its status as the gold... | PMC10349516 |
Materials and methods | PMC10349516 | |||
Recruiting patients | prostate, diabetes | PROSTATE, ACUTE BACTERIAL PROSTATITIS, BENIGN PROSTATIC HYPERPLASIA (BPH), HIGH BLOOD PRESSURE, PROSTATE CANCER, DIABETES | From January 2016 to December 2022, 800 patients who underwent transrectal prostate puncture guided by transrectal ultrasonography (TRUS) (12 + X core, all patients underwent preoperative magnetic resonance imaging (MRI) of the prostate, followed by 12-core systematic biopsy with or without targeted biopsy based on the... | PMC10349516 |
Clinical information | TG, prostate | PROSTATE | The baseline information was retrospectively acquired from the clinical digital information including age, BMI (body mass index), serum PSA (total PSA and free PSA), f/tPSA (free/total PSA ratio), prostate volume (PV), prostate-specific antigen density (PSAD), TC, TG, HDL, LDL, apo A-1, apo B, DRE results, TRUS finding... | PMC10349516 |
Nomogram development and evaluating | REGRESSION | To construct an accurate nomogram that predicts the likelihood of PCa, we carried out multivariable logistic regression analyses to determine the correlation between the relevant factors and PCa. We utilized the forward method in multivariable logistic regression analysis to identify independent predictors, and subsequ... | PMC10349516 | |
Statistical analysis | REGRESSION | The distribution of categorical variables was evaluated using Pearson’s Chi-square test, while the distribution of continuous variables was assessed using either the Mann-Whitney U test or Student’s t-test, depending on the distribution of the data. The multivariable logistic regression analysis was conducted using the... | PMC10349516 | |
Results | PMC10349516 | |||
Multivariable analysis predicting PCa | TG, prostate cancer | REGRESSION, PROSTATE CANCER | In multivariable logistic regression analysis, tPSA (P < 0.001), f/tPSA (P = 0.018), PSAD (P = 0.030), TG (P = 0.006), LDL (P < 0.001), DRE (P = 0.002) and TRUS (P = 0.009) were significantly related to the presence of PCa in biopsy (Table
Multivariate logistic regression models in the training group
Diagnostic accura... | PMC10349516 |
Nomogram to estimate the risk of PCa | TG | REGRESSION, PROSTATE | Using multivariate logistic regression, a predictive model was constructed. 7 of the initial 13 variables were incorporated into the predictive model (model 2), namely tPSA, f/tPSA, PSAD, TG, LDL, DRE, and TRUS, as predictors. Each variable is scored, and a straight line is drawn from the total score to determine harbo... | PMC10349516 |
Predictive model validation | prostate cancer | PROSTATE CANCER | The calibration plot, which used internal bootstrap sampling (n = 1000), indicated a high degree of consistency between the bias-corrected curve and the ideal curve (the 45-degree line) both in the training and validation sets, indicating that our nomogram accurately predicted the occurrence risk and demonstrated good ... | PMC10349516 |
Discussion | obesity, high-grade prostate cancer, RP, prostate malignancies, cancer, prostate, PCa, high-grade, prostate tumor, hypertriglyceridemia, metabolic syndrome, TG, prostate cancer, dyslipidemia | OBESITY, HYPERLIPIDEMIA, PROLIFERATION, CANCER, DISEASE, PROSTATE CANCER RECURRENT, COMPLICATIONS, PROSTATE, PROSTATE TUMOR, HYPERTRIGLYCERIDEMIA, METABOLIC SYNDROME, PROSTATE CANCER, TUMORIGENESIS, DYSLIPIDEMIA | PCa is a complicated disease characterized by phenotypes, and each patient appears to have an “individual” process. The lifestyle and nutritional preferences of an individual could influence the development of PCa. There was strong evidence that obesity, hyperlipidemia, and other components of metabolic syndrome signif... | PMC10349516 |
Electronic supplementary material | REGRESSION | Below is the link to the electronic supplementary material.
Additional File Table 1: Multivariate stepwise logistic regression analysis for predicting PCa in the training group for Model 1.
Additional File Table 2: Multivariate stepwise logistic regression analysis for predicting PCa in the training group for Model 2. | PMC10349516 | |
Acknowledgements | None. | PMC10349516 | ||
Authors’ contributions | W.W. | F.F., Y.Z. and Z.X. conceptualized and designed the framework of this study. Y.C. and F.L. completed the collation and conducted all analyses. Y.C., J.H. and Y.M. provided clinical expertise and aided in interpreting the results. P.Z., W.W. and H.Z. drafted the manuscript, figure, and table. All authors reviewed and ed... | PMC10349516 | |
Funding | This project was supported by Foshan “14th Five-Year” Medical Cultivation Key Specialties Construction Project (FSPY145003) and Clinical Drug Research. Foundation of Guangdong Province (Special Fund for Orthopedics Analgesia in Surgical Pharmacy) (2021ZT13). The funding bodies played no role in the design of the study ... | PMC10349516 | ||
Data availability | The data are not publicly shared because we do not have permission from the Ethics Review Committee to distribute the data. The analytic methods are available from the corresponding authors upon reasonable request. | PMC10349516 | ||
Declarations | PMC10349516 | |||
Ethics approval and consent to participate | The studies involving human participants were reviewed and approved by the Ethics Review Committee of Foshan Hospital of Traditional Chinese Medicine (Approval number. 20220520). All procedures followed applicable guidelines and regulations. Informed written consent was also obtained from the patients in this study. | PMC10349516 | ||
Consent for publication | Not applicable. | PMC10349516 | ||
Competing interests | The authors state that they have no competing interests in this study. | PMC10349516 | ||
References | PMC10349516 | |||
Background | To investigate if the correlation between left and right cerebral tissue oxygen saturation (SctO | PMC9906862 | ||
Methods | lung cancer | LUNG CANCER | Patients who underwent surgery for lung cancer were enrolled. Left and right SctO | PMC9906862 |
Results | Left–right SctO | PMC9906862 | ||
Conclusions | The correlation between left and right SctO | PMC9906862 | ||
Trial registration | SECONDARY | This study was a secondary analysis of a cohort study approved by the Clinical Research Review Board of Peking University First Hospital (#2017–1378) and was registered in the Chinese Clinical Trial Registry on 10/09/2017 ( | PMC9906862 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12871-023-02001-7. | PMC9906862 | ||
Keywords | PMC9906862 | |||
Background | hypoxia, hypercapnia | HYPOXIA | Near-infrared spectroscopy (NIRS) has been widely used in patients undergoing non-cardiac surgery because it is a non-invasive, continuous, and timely method for monitoring regional cerebral tissue oxygen saturation (SctOEvidence in healthy volunteers showed that respiratory parameters significantly influence the accur... | PMC9906862 |
Methods | PMC9906862 | |||
Ethic and registration | SECONDARY | This study was a secondary analysis of a cohort study which was approved by the Clinical Research Review Board of Peking University First Hospital (#2017–1378) and registered in the Chinese Clinical Trial Registry ( | PMC9906862 | |
Patient inclusion and exclusion criteria | Adult patients (age ≥ 55-year-old) who received OLV under general anesthesia with or without epidural or paravertebral block were enrolled. Patients were excluded if they met any of the following criteria: 1) no record of SctO | PMC9906862 | ||
Primary outcome | BLIND | The primary outcome was agreement of left–right SctOBaseline measurements were obtained before anesthesia induction, with the patients resting and breathing room air. The screen of the tissue oximeter was covered with an opaque bag to blind the anesthesia providers for monitoring. Dedicated research personnel checked t... | PMC9906862 | |
Secondary outcomes | Confusion | Secondary outcomes included the correlation of left–right SctOCorrelations of left–right ScODelirium was assessed twice daily (at 06:00–08:00 and 18:00–20:00) within postoperative 5 days using the Chinese version of the Confusion Assessment Method (CAM) in non-intubated patients and the CAM for intensive care unit (CAM... | PMC9906862 | |
Anesthesia and perioperative care | pain | All patients underwent the same monitoring on arrival at the operating room, including SpOAnesthesia was induced using propofol (2–4 mg/kg) and sufentanil (site-effect concentration, 0.2A double-lumen endotracheal tube was used for intubation. The tidal volume was set at 6Postoperative pain was assessed using numeric r... | PMC9906862 | |
Statistical analysis | PMC9906862 | |||
Power calculation | The Pearson’s correlation coefficient of left–right SctO | PMC9906862 |
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