Trials最新文献

{"title":"Inhaled sedation versus propofol in respiratory failure in the ICU (INSPiRE-ICU2): study protocol for a multicenter randomized controlled trial.","authors":"Brian O'Gara, Alexis L Serra, Joshua A Englert, Alisha Sachdev, Robert L Owens, Steven Y Chang, Pauline K Park, Daniel Talmor, Ida Sverud, Peter Sackey, Jeremy R Beitler","doi":"10.1186/s13063-025-08791-0","DOIUrl":"https://doi.org/10.1186/s13063-025-08791-0","url":null,"abstract":"<p><strong>Background: </strong>Patients undergoing invasive mechanical ventilation often require pharmacologic sedation to facilitate tolerance of this life-sustaining intervention, but sedatives currently used in routine care have substantial limitations. Isoflurane is an inhaled volatile anesthetic with pharmacologic properties potentially suitable to sedation of ventilator-dependent critically ill patients, but need for specialized drug administration equipment has limited its use historically to general anesthesia in the operating theatre. This trial will evaluate isoflurane, administered using a novel drug delivery system, for sedation of ventilator-dependent adult intensive care unit (ICU) patients in the United States (US).</p><p><strong>Methods: </strong>The Inhaled Sedation versus Propofol in Respiratory Failure in the ICU (INSPiRE-ICU2) is a phase 3, multicenter, randomized, controlled, assessor-blinded non-inferiority trial that will evaluate efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S, compared to intravenous propofol, for sedation of mechanically ventilated adult ICU patients. At 16 US hospitals, 235 enrolled patients requiring continuous sedation during invasive mechanical ventilation will be randomized in 1.5:1 ratio to inhaled isoflurane or intravenous propofol for sedation. Treatment duration is expected to be at least 12 h and may last up to 48 (± 6) h or until no longer needing continuous sedation, whichever occurs first. The primary endpoint is the percentage of time sedation depth is maintained within the targeted range (Richmond Agitation Sedation Scale - 1 to - 4), in the absence of rescue sedation, during the treatment period. Secondary superiority outcomes include opioid exposure, wake-up time, cognitive recovery after end-of-treatment, and preservation of spontaneous breathing effort.</p><p><strong>Discussion: </strong>The INSPiRE-ICU2 trial will help determine the potential role of isoflurane for sedation of ventilator-dependent adult patients in the ICU. Key trial design features, including adoption of the estimand framework and blinded assessments of sedation depth, pain, and cognitive recovery, will ensure a rigorous evaluation of isoflurane for ICU sedation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05327296. First registered on April 5, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"114"},"PeriodicalIF":2.0,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and evaluation of a school-based bullying prevention program (Bullying&You): study protocol for a cluster randomized trial.","authors":"Vanessa Jantzer, Franziska Neumayer, Stefan Lerch, Michael Kaess","doi":"10.1186/s13063-025-08821-x","DOIUrl":"https://doi.org/10.1186/s13063-025-08821-x","url":null,"abstract":"<p><strong>Background: </strong>Bullying victimization affects one in ten schoolchildren in Europe and has far-reaching negative consequences for mental health and school achievement. Although school-based bullying prevention programs seem overall capable of reducing the frequency of bullying, the continuous development, improvement, and rigorous evaluation of bullying prevention programs with enhanced feasibility and efficacy is critical. Consequently, we developed the program Bullying&You, which applies a blended-intervention approach to school-based bullying prevention based on latest empirical knowledge regarding effective program components and program-related facilitators. We aim to test its efficacy within a cluster randomized trial (CRT).</p><p><strong>Methods: </strong>Bullying&You will be implemented and evaluated in 40 schools (estimated total n = 8500 pupils) in Germany. The effectiveness of the program will be investigated in a CRT comparing 20 schools in the intervention group (IG; starting immediately with the program) with 20 schools in the waiting control group (CG; starting with a 1-year delay). The target group of the program are pupils in grades 3-9, as well as the whole school staff. All pupils will be asked to complete questionnaires concerning their bullying experiences (as victims, perpetrators, and bystanders) and mental health at baseline (T0) and two annual follow-ups (T1 and T2). The main endpoint of the trial is the reduction of bullying (prevalence of victims and perpetrators of direct, indirect, and cyberbullying) at 1-year follow-up (T1) in the IG compared to the CG. Secondary endpoints are psychopathology and self-harm behaviour. In addition, further research questions include (a) which specific components of the program prove to be most effective and (b) whether there are certain characteristics that predict program success at the individual level.</p><p><strong>Discussion: </strong>School-based bullying prevention programs still lack rigorous evidence for their efficacy. In addition, dissemination of bullying prevention programs has previously been hampered by the high need of resources required from schools for their implementation. The program's blended-intervention approach allows for a time-efficient and flexible implementation, while the continuous monitoring of the progress ensures program fidelity and strengthens adherence. If proven effective, Bullying&You has the potential to contribute to filling the gap in systematic dissemination of bullying prevention among youth.</p><p><strong>Trial registration: </strong>German Clinical Trials Register DRKS00028183. Registered on 02 March 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"115"},"PeriodicalIF":2.0,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143754664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tolerating bad health research (part 2): still as many bad trials, but more good ones too.","authors":"Anna Daly, Shaun Treweek, Genevieve Shiely Hayes, Frances Shiely","doi":"10.1186/s13063-025-08747-4","DOIUrl":"https://doi.org/10.1186/s13063-025-08747-4","url":null,"abstract":"<p><strong>Background: </strong>We previously published a study examining the risk of bias of a random selection of Cochrane systematic reviews. The purpose of our current study is to reassess the risk of bias of a cohort of Cochrane reviewed trials to see if our reassessment differs from the original Cochrane assessment and to determine whether the funder, having methodological support, or involving a statistician affected the risk of bias.</p><p><strong>Methods: </strong>We extracted data from 140 of 159 included trials from three countries, the UK, Canada, and Ireland, in our original cohort. The 19 remaining trials were excluded for a variety of reasons. We recorded the number of participants in the trial, the funder, if a statistician was involved in the trial, if there was any methodological support from a trials unit or clinical research facility, the sponsor, and whether the sponsor was involved in the design or conduct of the trial. The risk of bias of the 140 trials was re-assessed using the same tool as that used by the Cochrane authors.</p><p><strong>Results: </strong>Our judgement of overall high risk of bias was broadly consistent with the original Cochrane authors. The proportion of high risk of bias trials remained more or less where it was at 55%, but the proportion of low risk of bias trials increased from 9 to 16%. The proportion of unclear risk of bias trials changed accordingly. Compared to the original assessments, we judged more studies to be low risk of bias across all domains. The greatest variation was in the two blinding categories (participants and personnel; outcome assessor) and 'other bias'.</p><p><strong>Conclusions: </strong>More than half of trials in our UK, Canada, and Ireland cohort were at high risk of bias highlighting significant challenges in ensuring the integrity and reliability of research findings. Addressing bias in clinical trials is essential to uphold the credibility of scientific research and to ensure that healthcare interventions are based on sound evidence, ultimately improving patient outcomes.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"110"},"PeriodicalIF":2.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Whole stomach versus narrow gastric tube reconstruction after esophagectomy for esophageal cancer (ATHLETE trial): study protocol for a randomized controlled trial.","authors":"Junya Kitadani, Keiji Hayata, Taro Goda, Shinta Tominaga, Naoki Fukuda, Tomoki Nakai, Shotaro Nagano, Toshiyasu Ojima, Toshio Shimokawa, Manabu Kawai","doi":"10.1186/s13063-025-08823-9","DOIUrl":"https://doi.org/10.1186/s13063-025-08823-9","url":null,"abstract":"<p><strong>Background: </strong>There are two types of methods of creating a gastric conduit after esophagectomy for patients with esophageal cancer: narrow gastric tube reconstruction or whole stomach reconstruction. Whole stomach reconstruction with good blood perfusion was reported in a prospective cohort study to be safe and that it has the possibility to prevent anastomotic leakage (AL). We therefore planned a randomized controlled phase III study to investigate the superiority of whole stomach reconstruction over narrow gastric tube reconstruction after esophagectomy for esophageal cancer.</p><p><strong>Methods: </strong>This is a single center, two-arm, open-label, randomized phase III trial. We calculated that 65 patients in each arm of this study and total study population of 130 patients are required according to our historical data on narrow gastric tube reconstruction and prospective data on whole stomach reconstruction. In the narrow gastric tube group, a 3.5-cm-wide gastric tube is made along the greater curvature of the stomach using linear staplers. Otherwise, in the whole stomach group, after the lymphadenectomy of the lesser curvature and No.2, the stomach is cut just below the esophagogastric junction using a linear stapler. The primary endpoint of this study is the incidence of AL. Secondary endpoints are the occurrence rate of anastomotic stenosis, the occurrence rate of pneumonia, the occurrence rate of all postoperative complications, the occurrence rate of reflux esophagitis, quality of life evaluation by EORTC QLQ-C30 and EORTC OES-18, nutritional evaluation, the amount of blood loss, postoperative hospital stays, and blood flow evaluation. Complications are evaluated using the Clavien-Dindo classification (version 2.0), and those of grade II or higher are considered to be postoperative complications.</p><p><strong>Discussion: </strong>If the optimal method for creating a gastric conduit after esophagectomy is clarified, it may be possible to contribute to improving short-term and long-term surgical outcomes for patients undergoing surgery for esophageal cancer.</p><p><strong>Trial registration: </strong>The protocol of ATHLETE trial was registered in the UMIN Clinical Trials Registry as UMIN000050677 ( http://www.umin.ac.jp/ctr/index.htm ). Date of registration: March 26, 2023. Date of first participant enrollment: March 27, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"111"},"PeriodicalIF":2.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954340/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The selection of ventilation devices in children with mild or moderate upper respiratory tract infections: a randomised controlled trial.","authors":"Jing Shi, Xiang Liu, Wenjing Chen, Wenjuan Bao","doi":"10.1186/s13063-025-08815-9","DOIUrl":"https://doi.org/10.1186/s13063-025-08815-9","url":null,"abstract":"<p><strong>Purpose: </strong>Administering anaesthesia to children with upper respiratory tract infections (URTIs) increases the risk of perioperative respiratory adverse events (PRAEs). Several observational studies have suggested that the supraglottic airway (SGA) technique could be a potential alternative for airway management in children. This randomised controlled trial assesses whether using a SGA instead of an endotracheal tube (ETT) in children with mild or moderate URTIs affects the incidence of PRAEs.</p><p><strong>Methods: </strong>A total of 78 paediatric patients with mild or moderate URTIs who received either a SGA or ETT were included. Patients were monitored for adverse events such as cough, laryngospasm, bronchospasm, breath-holding, postoperative stridor or desaturation (< 90%) during the following stages: induction of anaesthesia, tube placement, surgery, tube removal and postanaesthesia care.</p><p><strong>Results: </strong>Throughout the perioperative period, 56.4% (44/78) of children experienced PRAEs. The incidence was 77.5% (31/40) in those receiving ETT and 34.1% (13/38) in those receiving SGA. The relative risk (RR) of PRAEs in children receiving SGA was 0.417 (95% CI: 0.248-0.701) compared with those receiving ETT (p < 0.001). Specifically, the incidence of minor PRAEs was significantly lower in the SGA group (28.9%, 11/38) compared with the ETT group (67.5%, 27/40) (RR: 0.429, 95% CI: 0.249-0.738, p < 0.001). There were significant differences between the groups in the incidence of perioperative cough (p = 0.043) and desaturation (p = 0.031).</p><p><strong>Conclusion: </strong>Using a SGA reduced the incidence of coughing, bronchospasm and oxygen desaturation, providing an acceptable alternative to ETT in children with mild or moderate URTIs.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"112"},"PeriodicalIF":2.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Worldwide trends in the quality and breadth of clinical investigations of medical devices over the past decade: a scoping review and evidence map.","authors":"David F Keane, Cherian Mathew, Ryan Longley, Rosie Dunne, Thomas Mathew, Elaine Harris, Paddy Gillespie, Abhay Pandit, Matthew D Griffin","doi":"10.1186/s13063-025-08793-y","DOIUrl":"https://doi.org/10.1186/s13063-025-08793-y","url":null,"abstract":"<p><strong>Background: </strong>Recent regulatory developments in Europe have enhanced the requirements for clinical investigations of medical devices, partly in response to a perceived need for a higher level of evidence that is publicly available. This scoping review aims to map published clinical investigations of medical devices by device type and clinical specialty and summarise key trial design aspects.</p><p><strong>Methods: </strong>We developed a search for EMBASE that identified clinical investigations of medical devices during two discrete 3-month periods at the end of 2012 and of 2022. Core information from observational studies was extracted along with details on study design in interventional studies. We developed an evidence map of published studies across device type and clinical specialty and summarised study design aspects.</p><p><strong>Results: </strong>We included 682 studies from 2012 and 1682 studies from 2022. Around a quarter of studies were interventional and the remainder being observational and primary outcomes of effectiveness were more common than efficacy. Key study design aspects were frequently unreported, including sample size justification, registration, randomisation technique and funders. Our evidence map demonstrated that predominantly, investigations were of implants and were in a cardiovascular setting. Clinical investigations were broadly similar between 2012 and 2022, though there was a reduction in the proportion of cardiovascular studies, a move in the share of studies coming out of Europe and North America towards Asia and a general improvement in the quality of study design reported.</p><p><strong>Conclusions: </strong>Implanted devices in cardiovascular disease and orthopaedics are the focus of a large proportion of published clinical investigations of medical devices. Reporting of key study design aspects of clinical investigations of medical devices are improving but are still below expected requirements.</p><p><strong>Registration: </strong>A pre-specified and published protocol was registered on figshare: doi.org/10.6084/m9.figshare.22276945.v1 on 15/03/2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"113"},"PeriodicalIF":2.0,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of ezetimibe and atorvastatin versus atorvastatin alone on short-term major adverse cardiac events after percutaneous coronary intervention, a double-blind placebo-controlled randomized clinical trial.","authors":"Hossein Farshidi, Badri Bijani, Seyed Alireza Sobhani, Farideh Dastsouz, Shahin Abbaszadeh","doi":"10.1186/s13063-025-08817-7","DOIUrl":"10.1186/s13063-025-08817-7","url":null,"abstract":"<p><strong>Background: </strong>Major cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are among the most common causes of death in patients. Lipid-lowering strategies seem to affect these events. Reaching the best regimen for controlling lipid abnormalities is important. This study aimed to compare the effect of ezetimibe and atorvastatin versus atorvastatin alone in short-term major cardiovascular events in patients after PCI in Bandar Abbas in 2018.</p><p><strong>Methods: </strong>This double-blinded randomized controlled trial was done in Bandar Abbas in 2018 on 224 patients. Patients were randomly divided into two groups either to receive ezetimibe and atorvastatin (group A) or atorvastatin alone (group B). Patients were followed for 1 month for major cardiovascular events and drug side effects. Data was analyzed using SPSS software.</p><p><strong>Results: </strong>Patients in the two groups had similar baseline characteristics. The mean low-density lipoproteins (LDL) level was 69.83 ± 28.8 in group A and 82.45 ± 29.9 in group B (P = 0.014). At the end of the study, high-sensitivity C-reactive protein (hs-CRP) values were notably lower in group A (P value = 0.005). Three (2.7%) patients in group A and 1 patient (0.9%) in group B had a myocardial infarction (P value = 0.313). Also, 11 patients (9.8%) in group A and 13 patients (11.6%) in group B had unstable angina (P value = 0.666). No patients had death, cerebrovascular event, or stent thrombosis in the two groups.</p><p><strong>Conclusion: </strong>Although adding ezetimibe to atorvastatin can decrease LDL and hs-CRP levels in short-term follow-up; it is not effective in lowering short-term major cardiovascular events in patients after PCI. Studies with longer-term follow-up are recommended.</p><p><strong>Trial registration: </strong>IRCT, IRCT20171028037047N1. Registered on 22 June 2018, https://irct.behdasht.gov.ir/trial/28808 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"108"},"PeriodicalIF":2.0,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11951807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143731824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER): study protocol for a randomised controlled trial.","authors":"Srinivas Marmamula, Suvarna Alladi, Keerthana Umapathy, Ving Fai Chan, Graeme MacKenzie, Lynne Lohfeld, Asha Latha Mettla, Sridevi Rayasam, Vijaya K Gothwal, Raja Narayanan, Giridhar Pyda, Harithaa P Chadalavada, Priya Thomas, Lovemore Nyasha Sigwadhi, Augusto Azuara-Blanco, Cliona McDowell, Susan McMullan, Lynn Murphy, Mike Clarke, Joshua R Ehrlich, Bonnielin Sweenor, Ciaran O'Neill, Shashidhar Komaravolu, Pallab K Maulik, G V S Murthy, Keshav Kumar, Anant Nyshadham, Achyuta Adhvaryu, Christopher McCabe, David E Bloom, Jinkook Lee, Frank Lin, Seán Coghlan, Rohit C Khanna, Nathan Congdon","doi":"10.1186/s13063-025-08813-x","DOIUrl":"https://doi.org/10.1186/s13063-025-08813-x","url":null,"abstract":"<p><strong>Background: </strong>Longitudinal observational studies have found an association between vision impairment and accelerated decline in cognition. However, no randomised trials have assessed the possible benefit of vision correction on cognitive change. We present the protocol for a three-year randomised controlled trial designed to assess the impact of spectacles for distance and/or near vision correction on cognitive change among community-dwelling elderly participants in India.</p><p><strong>Methods: </strong>Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER) is a single-centre, open-label, parallel-group, individually-randomised trial. Participants (760 total, 380 in each arm) aged ≥ 60 years with correctable vision impairment at distance and/or near (presenting visual acuity < 6/18 in the better-seeing eye and improving to > = 6/18 with spectacles and/or presenting near vision worse than N6 at 40 cm and improving to N6 with spectacles), normal hearing (able to repeat at least three out of six words whispered from a 50 cm distance in the better ear) and normal cognition (Hindi Mini-mental Status Examination score > 18/31) will be enrolled. After a comprehensive eye examination, intervention group participants will receive distance, near, or bifocal spectacles, while controls will receive a prescription and spectacles at the end of the trial. The primary outcome will be the three-year change in Longitudinal Aging Study in India-Diagnostic Assessment of Dementia (LASI DAD) global cognitive factor score, with and without adjustment for baseline score, age, gender, education and other potential confounders.</p><p><strong>Conclusion: </strong>CLEVER is designed to assess the effectiveness of spectacles as a low-cost intervention to prevent or delay cognitive decline.</p><p><strong>Trial registration: </strong>This trial is registered with ClinicalTrials.gov, number NCT05458323, February 15, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"109"},"PeriodicalIF":2.0,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954208/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sharing clinical trial results with participants: important, expected and possible.","authors":"Annabelle South, Claire Bale, Enhad Chowdhury, Alexander Churchill, Kim Donoghue, Simon Grieveson, Charlotte Hartley, Catriona Manville, Angela Polanco, Kieran Prior, Sheona Scales, Kirstie Shearman, Mahesh K B Parmar","doi":"10.1186/s13063-025-08802-0","DOIUrl":"10.1186/s13063-025-08802-0","url":null,"abstract":"<p><p>Participants in clinical trials should be pro-actively offered the results of trials in which they have participated. This should be done in a way that is accessible and understandable for all participants. People who have taken part in research have a right to know the results of the studies in which they have taken part and should be given the option of receiving these results. Most trial participants want to receive the overall results. Key reasons for sharing results include respecting participants' contributions, enhancing their understanding of research benefits, increasing transparency, and potentially improving recruitment and retention. We propose 8 principles to guide sharing of results with trial participants:1. Trial teams should pro-actively offer overall study results to all clinical trial participants, irrespective of what the results show.2. Participants should be given the choice of whether to receive research results.3. Results should be offered to participants in a timely manner.4. Trial teams should manage participants' expectations around when the results will be available.5. Results should be offered in a way that is accessible to participants, both in terms of the communication mechanism and the content.6. Patient and public involvement is essential in sharing results with participants.7. Sharing results with participants requires resources.8. Consideration needs to be given to potential barriers/challenges to sharing results with participants from the planning stage of the study.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"107"},"PeriodicalIF":2.0,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11948716/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143720631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of driving pressure-guided individualized positive end-expiratory pressure (PEEP) ventilation strategy on postoperative atelectasis in patients undergoing laparoscopic surgery as assessed by ultrasonography: study protocol for a prospective randomized controlled trial.","authors":"Yi Zhang, Jiayu Zhu, Chunhua Xi, Guyan Wang","doi":"10.1186/s13063-025-08819-5","DOIUrl":"10.1186/s13063-025-08819-5","url":null,"abstract":"<p><strong>Background: </strong>Ventilator-induced lung injury caused by mechanical ventilation under general anesthesia as well as CO₂ pneumoperitoneum and special positions for laparoscopy may increase the risk of postoperative pulmonary complications (PPCs). Lung protective ventilation under general anesthesia is advised by the guidelines to lower the risk of PPCs in surgical patients. However, there is considerable controversy about the optimal level of positive end-expiratory pressure (PEEP) and how to set it. Driving pressure reflects the overall respiratory stress and high driving pressure is an independent risk factor for PPCs. The purpose of this study is to explore whether driving pressure-guided individualized PEEP ventilation can lower the incidence of postoperative atelectasis by improving respiratory mechanics during laparoscopic surgery consequently lowering the incidence of PPCs compared with the traditional fixed PEEP ventilation strategy.</p><p><strong>Methods: </strong>The study will be a single-center, prospective, randomized controlled clinical study. A total of 106 adult patients with medium-to-high-risk PPCs undergoing laparoscopic surgery for more than 2 h will be randomly assigned in a 1:1 ratio to receive an individualized PEEP guided by minimum driving pressure (group D) or a fixed PEEP of 5 cmH₂O (group C). Patients in group C will maintain a PEEP of 5 cmH₂O throughout the whole process, and patients in group D will be administered individualized PEEP after the start of pneumoperitoneum to achieve minimum driving pressure until the end of the operation. The primary outcome is the LUS score at 24 h postoperatively. The secondary outcomes are the LUS scores at other time points, intraoperative respiratory mechanics and oxygenation index, incidence and specific types of PPCs at 7 days postoperatively.</p><p><strong>Discussion: </strong>This study will better evaluate the effect of individualized PEEP application guided by driving pressure on the incidence of postoperative atelectasis based on ultrasound assessment consequently the incidence of PPCs in patients undergoing prolonged laparoscopic surgery. The results may provide a clinical evidence for optimizing perioperative lung protection strategies.</p><p><strong>Trial registration: </strong>www.chictr.org.cn ChiCTR2300079041. Registered on December 25, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"106"},"PeriodicalIF":2.0,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11948704/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143721657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}