Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
Recruiting · NCT07359261 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Known or suspected esophageal varices
- Esophageal surgery within 3 months
- Known esophageal stricture or perforation
- Active upper gastrointestinal bleeding
- Severe coagulopathy (INR \>3.0 or platelet count \<30,000/μL)
- Known or suspected intracranial hypertension without intracranial pressure monitoring device demonstrating controlled intracranial pressure (\<20 mmHg)
- Severe hemodynamic instability at treating physician discretion
- Known pregnancy
- Moribund state with expected survival \<48 hours
- Receiving extracorporeal membrane oxygenation (ECMO)
- Open abdomen post-operatively
- Previous enrollment in this study
- Any other contraindication to esophageal balloon placement as determined by clinical team
Where it is running
2 locations listed.
- University of Alberta Hospital - Edmonton, Alberta, Canada
- Sturgeon Community Hospital - St. Albert, Alberta, Canada