Esophageal pressure to guide ventilator settings in obese adults with respiratory failure
Tests esophageal pressure-guided ventilator settings versus standard care in obese adults needing breathing machines.
Plain-language title generated from the registry record
Registry title: Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
Key facts
- Where
- Edmonton and St. Albert, CanadaSee the 2 sites
- Phase
- Phase 2
Where in Canada
- University of Alberta HospitalEdmonton, CanadaTaking people
- Sturgeon Community HospitalSt. Albert, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Alberta
- Trial code
- NCT07359261
- Record updated
- 13 April 2026
- Original description
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.Read full original descriptionShow less
Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure
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.
Inclusion: Age 18 years or older; Body mass index ≥30 kg/m²; Intubated and receiving passive mechanical ventilation; Within 24 hours of intubation; Anticipated need for mechanical ventilation for at least 48 hours.
Exclusion: Esophageal surgery within 3 months; Receiving extracorporeal membrane oxygenation (ECMO); Previous enrollment in this study; Known esophageal stricture or perforation; Active upper gastrointestinal bleeding; Known or suspected intracranial hypertension without intracranial pressure monitoring device demonstrating controlled intracranial pressure (<20 mmHg); Severe coagulopathy (INR >3.0 or platelet count <30,000/μL); Known or suspected esophageal varices; Severe hemodynamic instability at treating physician discretion; Known pregnancy; Moribund state with expected survival <48 hours; Open abdomen post-operatively; Any other contraindication to esophageal balloon placement as determined by clinical team.