Personalized PEEP using esophageal pressure for adults with obesity on a ventilator

Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure

This test checks whether using esophageal pressure to set PEEP helps adults with obesity who are on a mechanical ventilator.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 2 sites (Edmonton, Alberta and 1 other locations)
• Trial ID: NCT07359261 on ClinicalTrials.gov

What this trial studies

This randomized, controlled feasibility vanguard will enroll 30 adults with BMI ≥30 kg/m2 who require invasive mechanical ventilation within 24 hours of intubation and randomize them 1:1 to esophageal pressure–guided PEEP titration or standard care. The intervention uses an esophageal balloon to target an end-expiratory transpulmonary pressure of 0–2 cmH2O and adjusts PEEP based on those measurements, while the control group receives usual PEEP management. The primary objective is to determine the feasibility of conducting a larger definitive trial, and secondary outcomes include applied PEEP levels, respiratory mechanics, and clinical outcomes. Enrollment is limited to two hospitals in the Edmonton Zone and the protocol excludes patients with contraindications to esophageal balloon placement or those on ECMO.

Who should consider this trial

Good fit: Adults (≥18 years) with BMI ≥30 kg/m2 who are intubated, within 24 hours of intubation, receiving passive mechanical ventilation, and expected to require ventilation for at least 48 hours are the intended participants.

Not a fit: Patients with contraindications to esophageal balloon placement (for example esophageal varices, recent esophageal surgery, esophageal perforation, active upper GI bleeding, or severe coagulopathy), those on ECMO, or those expected to die within 48 hours are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could enable more personalized PEEP settings that improve lung mechanics and oxygenation and potentially reduce ventilator-related lung injury in obese patients.

How similar studies have performed: Similar esophageal pressure–guided PEEP approaches have been tested in ARDS and produced physiologic improvements in some early trials but mixed clinical results in larger studies, so use specifically in obese ventilated patients remains relatively novel and unproven.

Eligibility criteria

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 this trial is running

Edmonton, Alberta and 1 other locations

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

Study contacts

• Study coordinator: Fernando G Zampieri, MD

Conditions Respiratory Failure; PEEP; obesity; mechanical ventilation