Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:47 AM
Study NCT ID:
NCT07359261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Catheter-related complications', 'timeFrame': '7 days', 'description': 'Occurrence of esophageal catheter complications (perforation, bleeding)'}], 'primaryOutcomes': [{'measure': 'Feasibility of conducting a definitive trial (composite)', 'timeFrame': '14 months', 'description': 'Composite feasibility assessment including: (1) Recruitment rate (patients enrolled per month, target 1-1.5/month); (2) Successful esophageal catheter placement rate in intervention arm; (3) Protocol adherence (percentage of scheduled transpulmonary pressure measurements completed, compliance with PEEP titration algorithm); (4) Data completeness for average PEEP over 7 days.'}], 'secondaryOutcomes': [{'measure': 'Average PEEP', 'timeFrame': '7 days', 'description': 'Key secondary endpoint. Mean positive end-expiratory pressure during mechanical ventilation'}, {'measure': 'Driving Pressure', 'timeFrame': '7 days', 'description': 'Difference in driving pressure between groups'}, {'measure': 'Partial oxygen pressure over inspired oxygen fraction ratio', 'timeFrame': '7 days', 'description': 'P/F ratio'}, {'measure': 'Days alive and free of mechanical ventilation', 'timeFrame': 'Up to hospital discharge assessed up to 30 days', 'description': 'Days alive and free of mechanical ventilation'}, {'measure': 'Days alive and outside the intensive care unit', 'timeFrame': 'Up to hospital discharge assessed up to 30 days', 'description': 'Days alive and outside the intensive care unit'}, {'measure': 'Hospital Mortality', 'timeFrame': 'Up to hospital discharge assessed up to 30 days', 'description': 'Hospital Mortality'}, {'measure': 'Hemodynamics Instability', 'timeFrame': 'Up to 7 days', 'description': 'Hemodynamics Instability during PEEP Titration defined as a new start of vasopressors at any dose or an increase in vasopressor dose by 20%'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PEEP', 'obesity', 'mechanical ventilation'], 'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': '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/m2 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Body mass index ≥30 kg/m²\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 \\<30,000/μL)\n* Known or suspected intracranial hypertension without intracranial pressure monitoring device demonstrating controlled intracranial pressure (\\<20 mmHg)\n* Severe hemodynamic instability at treating physician discretion\n* Known pregnancy\n* Moribund state with expected survival \\<48 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'}, 'identificationModule': {'nctId': 'NCT07359261', 'acronym': 'TAILOR-PEEP', 'briefTitle': 'Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure', 'orgStudyIdInfo': {'id': 'Pro00154874'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esophageal-balloon guided', 'description': '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/F ratio \\<200). PEEP adjusted in 2 cmH2O increments with 5-minute stabilization periods. Safety limits: transpulmonary driving pressure \\<15 cmH2O, end-inspiratory transpulmonary pressure \\<20 cmH2O. Reassessment twice daily (approximately 0800 and 2200). Catheter removed prior to extubation or at 28 days, whichever occurs first.', 'interventionNames': ['Procedure: Esophageal pressure-guided PEEP titration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'PEEP management according to current standard practice. For patients meeting ARDS criteria, PEEP titrated using the ARDSNet PEEP/FiO2 table. For non-ARDS patients, PEEP titrated per local practice to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics. No esophageal pressure monitoring.', 'interventionNames': ['Other: Standard care PEEP management']}], 'interventions': [{'name': 'Esophageal pressure-guided PEEP titration', 'type': 'PROCEDURE', 'otherNames': ['Transpulmonary pressure-guided PEEP titration', 'Pes-guided PEEP management'], 'description': '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/F \\<200). Safety limits enforced: transpulmonary driving pressure \\<15 cmH2O, end-inspiratory transpulmonary pressure \\<20 cmH2O. Measurements performed twice daily. Catheter removed at extubation or day 28.', 'armGroupLabels': ['Esophageal-balloon guided']}, {'name': 'Standard care PEEP management', 'type': 'OTHER', 'description': 'PEEP management per institutional standard practice without esophageal pressure monitoring. For patients meeting ARDS criteria, PEEP titrated using ARDSNet low PEEP/FiO2 table. For non-ARDS patients, PEEP titrated to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics per treating clinician judgment.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'contacts': [{'name': 'Fernando G Zampieri, MD', 'role': 'CONTACT', 'email': 'fzampier@ualberta.ca', 'phone': '780.492.9951'}], 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'St. Albert', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Sturgeon Community Hospital', 'geoPoint': {'lat': 53.63344, 'lon': -113.63533}}], 'centralContacts': [{'name': 'Fernando G Zampieri, MD', 'role': 'CONTACT', 'email': 'fzampier@ualberta.ca', 'phone': '780.492.9951'}, {'name': 'Caylin Chadwick, MSc', 'role': 'CONTACT', 'email': 'Caylin.Chadwick@albertahealthservices.ca', 'phone': '780.492.9951'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'accessCriteria': 'Anonymized data may be shared after discussion with study steering committee, approval from ethics from University of Alberta, and establishment of data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}