Actively Recruiting
Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
Led by University of Alberta · Updated on 2026-04-13
30
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Body mass index 30 kg/m8
- Intubated and receiving passive mechanical ventilation
- Within 24 hours of intubation
- Anticipated need for mechanical ventilation for at least 48 hours
You will not qualify if you...
- 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/bcL)
- Known or suspected intracranial hypertension without controlled intracranial pressure monitoring
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Alberta Hospital
Edmonton, Alberta, Canada
Actively Recruiting
2
Sturgeon Community Hospital
St. Albert, Alberta, Canada
Actively Recruiting
Research Team
F
Fernando G Zampieri, MD
CONTACT
C
Caylin Chadwick, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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