Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

NCT07359261 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Alberta

Phase

Phase 2

Started

2026-02-05

Last updated

2026-04-13

Condition(s) studied

Respiratory Failure

Investigational drug(s) / intervention(s)

Esophageal pressure-guided PEEP titrationStandard care PEEP management

Esophageal pressure-guided PEEP titration: PEEP titration guided by transpulmonary pressure measurements using esophageal manometry. Esophageal balloon catheter inserted within 4 hours of randomization, positioned at 35-40 cm depth with position verified by cardiac oscillations and occlusion test. PEEP titrated in 2 cmH2O increments targeting end-expiratory transpulmonary pressure 0-2 cmH2O, with option to target up to 8 cmH2O for severe hypoxemia (P/F \<200). Safety limits enforced: transpulmonary driving pressure \<15 cmH2O, end-inspiratory transpulmonary pressure \<20 cmH2O. Measurements performed twice daily. Catheter removed at extubation or day 28.

Standard care PEEP management: PEEP management per institutional standard practice without esophageal pressure monitoring. For patients meeting ARDS criteria, PEEP titrated using ARDSNet low PEEP/FiO2 table. For non-ARDS patients, PEEP titrated to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics per treating clinician judgment.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Feasibility of conducting a definitive trial (composite) — 14 months
Composite feasibility assessment including: (1) Recruitment rate (patients enrolled per month, target 1-1.5/month); (2) Successful esophageal catheter placement rate in intervention arm; (3) Protocol adherence (percentage of scheduled transpulmonary pressure measurements completed, compliance with PEEP titration algorithm); (4) Data completeness for average PEEP over 7 days.

Trial sites (2)

Facility	City	Region	Status
University of Alberta Hospital	Edmonton	Alberta	Recruiting
Sturgeon Community Hospital	St. Albert	Alberta	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07359261 on ClinicalTrials.gov ↗ ← All trials in Canada