Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About 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.

Eligibility criteria

Qualifiers

Age 18 years or older

Body mass index ≥30 kg/m²

Intubated and receiving passive mechanical ventilation

Within 24 hours of intubation

Disqualifiers

Known or suspected esophageal varices

Esophageal surgery within 3 months

Known esophageal stricture or perforation

Active upper gastrointestinal bleeding

Trial design

Treatments tested in this trial

  • Esophageal pressure-guided PEEP titration
  • Standard care PEEP management

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators