Recruiting
Phase 2

PEEP Titration

Sponsor:

University of Alberta

Code:

NCT07359261

Conditions

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Esophageal pressure-guided PEEP titration

Standard care PEEP management

Study Details

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.

Conditions

Respiratory Failure

Study ID

NCT07359261

Start date

Feb 5, 2026

Status verified date

Apr, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Feasibility of conducting a definitive trial (composite) [ Time Frame: 14 months ]

Central Contacts and Locations

Central contacts

Fernando G Zampieri, MD

780.492.9951fzampier@ualberta.ca

Caylin Chadwick, MSc

780.492.9951Caylin.Chadwick@albertahealthservices.ca

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Fernando G Zampieri, MD

780.492.9951fzampier@ualberta.ca

Sturgeon Community Hospital

Recruiting

St. Albert, Alberta, Canada

Contacts

Oleksa Rewa, MD

780.492.995rewa@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • PEEP
  • obesity
  • mechanical ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-04-13.