NCT07359261RecruitingPhase 2
Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 5 Feb 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Alberta
- Diseases
- Obesity
- NCT number
- NCT07359261
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 5 Feb 2026 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Esophageal surgery within 3 months
- Receiving extracorporeal membrane oxygenation (ECMO)
- Previous enrollment in this study
Other illness
- 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)
Lab values
- Severe coagulopathy (INR \>3.0 or platelet count \<30,000/μL)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Sturgeon Community Hospital Coordinator of this site? Confirm its status | St. Albert | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.