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Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
University of Alberta Hospital
RECRUITING
Edmonton
Sturgeon Community Hospital
RECRUITING
St. Albert
Contact Information
Primary
Fernando G Zampieri, MD
fzampier@ualberta.ca
780.492.9951
Backup
Caylin Chadwick, MSc
Caylin.Chadwick@albertahealthservices.ca
780.492.9951
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 30
Treatments
Experimental: Esophageal-balloon guided
Esophageal balloon catheter placed within 4 hours of randomization. PEEP titrated to achieve end-expiratory transpulmonary pressure of 0-2 cmH2O (up to 8 cmH2O for P/F ratio \<200). PEEP adjusted in 2 cmH2O increments with 5-minute stabilization periods. Safety limits: transpulmonary driving pressure \<15 cmH2O, end-inspiratory transpulmonary pressure \<20 cmH2O. Reassessment twice daily (approximately 0800 and 2200). Catheter removed prior to extubation or at 28 days, whichever occurs first.
Active_comparator: Standard of Care
PEEP management according to current standard practice. For patients meeting ARDS criteria, PEEP titrated using the ARDSNet PEEP/FiO2 table. For non-ARDS patients, PEEP titrated per local practice to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics. No esophageal pressure monitoring.
Related Therapeutic Areas
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov