RecruitingPhase 2NCT07359261

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

Sponsor

University of Alberta

Enrollment

30 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

Respiratory Failure

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria13

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

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Interventions

PROCEDUREEsophageal 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.

OTHERStandard 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.