Esophageal Pressure-Guided PEEP for Obesity

(TAILOR-PEEP Trial)

Not yet recruiting at 1 trial location

Overseen By Caylin Chadwick, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Disqualifiers: Esophageal varices, Surgery, Bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for obese patients with a BMI of 30 kg/m2 or higher who are on mechanical ventilation due to respiratory impairment. It's designed to see if managing their breathing support using esophageal pressure measurements can help more than standard care.

Inclusion Criteria

Body mass index ≥30 kg/m²

I am 18 years old or older.

I was put on a breathing machine within the last day.

Exclusion Criteria

I have or might have enlarged veins in my esophagus.

Severe coagulopathy (INR >3.0 or platelet count <30,000/μL)

Severe hemodynamic instability at treating physician discretion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either esophageal pressure-guided PEEP titration or standard care management

Up to 28 days

Daily reassessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days

Feasibility Assessment

Assessment of feasibility for conducting a larger definitive trial

14 months

What Are the Treatments Tested in This Trial?

Interventions

• Esophageal pressure-guided PEEP titration

Trial Overview

The study compares two ways to set the positive end-expiratory pressure (PEEP) in ventilated obese patients: one uses standard care guidelines, and the other adjusts PEEP based on esophageal pressure readings. The goal is to find out which method works best for lung function.

How Is the Trial Designed?

Group I: Esophageal-balloon guided Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+