NCT07359261 Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
| NCT ID | NCT07359261 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Alberta |
| Condition | Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-05 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2026-02-05 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07359261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07359261 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07359261 currently recruiting?
Yes, NCT07359261 is actively recruiting participants. Contact the research team at fzampier@ualberta.ca for enrollment information.
Where is the NCT07359261 trial being conducted?
This trial is being conducted at Edmonton, Canada, St. Albert, Canada.
Who is sponsoring the NCT07359261 clinical trial?
NCT07359261 is sponsored by University of Alberta. The trial plans to enroll 30 participants.