Personalized PEEP using esophageal pressure for adults with obesity on a ventilator
Official title: Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure
Run by University of Alberta · NCT07359261 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Status | Recruiting |
| Started | February 5, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07359261 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
University of Alberta Hospital
Edmonton, Alberta, Canada Recruiting -
Sturgeon Community Hospital
St. Albert, Alberta, Canada Recruiting
Study contacts
- Study coordinator: Fernando G Zampieri, MD
- Email: fzampier@ualberta.ca
- Phone: 780.492.9951
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.