Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

Recruiting now · Phase 2

Conditions studied: Respiratory Failure

In brief

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.

Key facts

Study ID

NCT07359261

Run by

University of Alberta

People needed

30

Starts

2026-02-05

Expected to finish

2027-01-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
• Sturgeon Community Hospital — St. Albert, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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