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Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

RecruitingPhase 2Ages 18 Years - anyAllUniversity of Alberta
NCT07359261 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older * Body mass index โ‰ฅ30 kg/mยฒ * 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/ฮผL) * 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
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What it tests

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

2 sites
University of Alberta Hospital
Edmonton, Canada
Sturgeon Community Hospital
St. Albert, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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