Clinical trial

Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

Recruiting now · Phase 2 · 1 countries · Registry ID NCT07359261

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionRespiratory Failure

Full registry 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

Treatments and study arms

Esophageal pressure-guided PEEP titration

Procedure

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

Other

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.

Primary outcomes

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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

University of Alberta Hospital🇨🇦 Edmonton, Alberta, Canada

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Fernando G Zampieri, MDContact

Email · Call 780.492.9951

Sturgeon Community Hospital🇨🇦 St. Albert, Alberta, Canada

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Oleksa Rewa, MDContact

Email · Call 780.492.995