Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07359261

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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