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Recruiting NCT07359261

Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

Phase II Interventional Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esophageal pressure-guided PEEP titration, Standard care PEEP management.
Who it may be relevant to
Registry conditions: Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transpulmonary Assessment for Individualized Lung Optimization in Patients Living With Obesity Research - Positive End-Expiratory Pressure

Overview

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.

Interventions

  • Procedure Esophageal pressure-guided PEEP titration
    PEEP titration guided by transpulmonary pressure measurements using esophageal manometry. Esophageal balloon catheter inserted within 4 hours of randomization, positioned at 35-40 cm depth with position verified by cardiac oscillations and occlusion test. PEEP titrated in 2 cmH2O increments targeting end-expiratory transpulmonary pressure 0-2 cmH2O, with option to target up to 8 cmH2O for severe hypoxemia (P/F \<200). Safety limits enforced: transpulmonary driving pressure \<15 cmH2O, end-inspir
  • Other Standard care PEEP management
    PEEP management per institutional standard practice without esophageal pressure monitoring. For patients meeting ARDS criteria, PEEP titrated using ARDSNet low PEEP/FiO2 table. For non-ARDS patients, PEEP titrated to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics per treating clinician judgment.

Primary outcome measures

  • Feasibility of conducting a definitive trial (composite) [Time frame: 14 months]
Secondary outcome measures (7)
  • Average PEEP [Time frame: 7 days]
  • Driving Pressure [Time frame: 7 days]
  • Partial oxygen pressure over inspired oxygen fraction ratio [Time frame: 7 days]
  • Days alive and free of mechanical ventilation [Time frame: Up to hospital discharge assessed up to 30 days]
  • Days alive and outside the intensive care unit [Time frame: Up to hospital discharge assessed up to 30 days]
  • Hospital Mortality [Time frame: Up to hospital discharge assessed up to 30 days]
  • Hemodynamics Instability [Time frame: Up to 7 days]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older
  • Body mass index ≥30 kg/m²
  • 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/μL)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • University of Alberta Hospital — Edmonton
  • Sturgeon Community Hospital — St. Albert

Identifiers

NCT: NCT07359261 · Pro00154874

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗