[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620564":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":43,"responsibleParty":72,"collaborators":33,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":33,"enrollmentInfo":84,"targetDuration":33,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":46,"whyStopped":33,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Esophageal-balloon guided","EXPERIMENTAL","Esophageal balloon catheter placed within 4 hours of randomization. PEEP titrated to achieve end-expiratory transpulmonary pressure of 0-2 cmH2O (up to 8 cmH2O for P\u002FF ratio \\\u003C200). PEEP adjusted in 2 cmH2O increments with 5-minute stabilization periods. Safety limits: transpulmonary driving pressure \\\u003C15 cmH2O, end-inspiratory transpulmonary pressure \\\u003C20 cmH2O. Reassessment twice daily (approximately 0800 and 2200). Catheter removed prior to extubation or at 28 days, whichever occurs first.",[13],"Procedure: Esophageal pressure-guided PEEP titration",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR","PEEP management according to current standard practice. For patients meeting ARDS criteria, PEEP titrated using the ARDSNet PEEP\u002FFiO2 table. For non-ARDS patients, PEEP titrated per local practice to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics. No esophageal pressure monitoring.",[19],"Other: Standard care PEEP management",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Esophageal pressure-guided PEEP titration","PEEP titration guided by transpulmonary pressure measurements using esophageal manometry. Esophageal balloon catheter inserted within 4 hours of randomization, positioned at 35-40 cm depth with position verified by cardiac oscillations and occlusion test. PEEP titrated in 2 cmH2O increments targeting end-expiratory transpulmonary pressure 0-2 cmH2O, with option to target up to 8 cmH2O for severe hypoxemia (P\u002FF \\\u003C200). Safety limits enforced: transpulmonary driving pressure \\\u003C15 cmH2O, end-inspiratory transpulmonary pressure \\\u003C20 cmH2O. Measurements performed twice daily. Catheter removed at extubation or day 28.",[9],[27,28],"Transpulmonary pressure-guided PEEP titration","Pes-guided PEEP management",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Standard care PEEP management","PEEP management per institutional standard practice without esophageal pressure monitoring. For patients meeting ARDS criteria, PEEP titrated using ARDSNet low PEEP\u002FFiO2 table. For non-ARDS patients, PEEP titrated to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics per treating clinician judgment.",[15],null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Fernando G Zampieri, MD","CONTACT","780.492.9951","fzampier@ualberta.ca",{"name":41,"role":37,"phone":38,"phoneExt":33,"email":42},"Caylin Chadwick, MSc","Caylin.Chadwick@albertahealthservices.ca",[44,59],{"facility":45,"status":46,"city":47,"state":48,"zip":33,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of Alberta Hospital","RECRUITING","Edmonton","Alberta","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-113.46871,53.55014,{"lat":55,"lon":54},[58],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},{"facility":60,"status":46,"city":61,"state":48,"zip":33,"country":49,"countryCode":50,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Sturgeon Community Hospital","St. Albert",{"type":52,"coordinates":63},[64,65],-113.63533,53.63344,{"lat":65,"lon":64},[68],{"name":69,"role":37,"phone":70,"phoneExt":33,"email":71},"Oleksa Rewa, MD","780.492.995","rewa@ualberta.ca",{"type":73,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100620564","phase-2-transpulmonary-assessment-for-individualized-lung-optimization-in-obese-patients-100620564",false,"NCT07359261","Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients","Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure","TAILOR-PEEP","Inclusion Criteria:\n\n* Age 18 years or older\n* Body mass index ≥30 kg\u002Fm²\n* Intubated and receiving passive mechanical ventilation\n* Within 24 hours of intubation\n* Anticipated need for mechanical ventilation for at least 48 hours\n\nExclusion Criteria:\n\n* Known or suspected esophageal varices\n* Esophageal surgery within 3 months\n* Known esophageal stricture or perforation\n* Active upper gastrointestinal bleeding\n* Severe coagulopathy (INR \\>3.0 or platelet count \\\u003C30,000\u002FμL)\n* Known or suspected intracranial hypertension without intracranial pressure monitoring device demonstrating controlled intracranial pressure (\\\u003C20 mmHg)\n* Severe hemodynamic instability at treating physician discretion\n* Known pregnancy\n* Moribund state with expected survival \\\u003C48 hours\n* Receiving extracorporeal membrane oxygenation (ECMO)\n* Open abdomen post-operatively\n* Previous enrollment in this study\n* Any other contraindication to esophageal balloon placement as determined by clinical team","ALL","18 Years",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","This protocol describes a randomized controlled feasibility vanguard study designed to investigate the implementation and effects of esophageal pressure-guided positive end-expiratory pressure (PEEP) titration in patients with high body mass index (BMI) mechanically ventilated patients at the Edmonton Zone. The study will enroll 30 patients with body mass index (BMI) \\>=30 kg\u002Fm2 who require invasive mechanical ventilation, randomizing them in a 1:1 ratio to receive either esophageal pressure-guided PEEP titration or standard care management. The primary objective focuses on establishing the feasibility of conducting a larger definitive trial, while secondary objectives examine differences in applied PEEP levels, respiratory mechanics, and clinical outcomes between groups. The intervention protocol targets end-expiratory transpulmonary pressure of 0-2 cmH2O.",[92],"Respiratory Failure",[94,95,96],"PEEP","obesity","mechanical ventilation","2026-04-07",{"date":99,"type":100},"2026-04-13","ACTUAL",{"date":102,"type":100},"2026-02-05",{"date":104,"type":86},"2027-01-01",{"name":5,"class":6},2]