Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients (NCT07359261) | Clinical Trial Compass
RecruitingPhase 2
Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
Canada30 participantsStarted 2026-02-05
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of conducting a definitive trial (composite)