Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07359261

Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Respiratory Failure Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophageal pressure-guided PEEP titration

Procedure

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-inspiratory transpulmonary pressure <20 cmH2O. Measurements performed twice daily. Catheter removed at extubation or day 28.

Other names: Transpulmonary pressure-guided PEEP titration, Pes-guided PEEP management

Standard care PEEP management

Other

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 outcomes

  1. Feasibility of conducting a definitive trial (composite)

    Time frame: 14 months

    Composite feasibility assessment including: (1) Recruitment rate (patients enrolled per month, target 1-1.5/month); (2) Successful esophageal catheter placement rate in intervention arm; (3) Protocol adherence (percentage of scheduled transpulmonary pressure measurements completed, compliance with PEEP titration algorithm); (4) Data completeness for average PEEP over 7 days.

Secondary outcomes

  1. Average PEEP

    Time frame: 7 days

    Key secondary endpoint. Mean positive end-expiratory pressure during mechanical ventilation

  2. Driving Pressure

    Time frame: 7 days

    Difference in driving pressure between groups

  3. Partial oxygen pressure over inspired oxygen fraction ratio

    Time frame: 7 days

    P/F ratio

  4. Days alive and free of mechanical ventilation

    Time frame: Up to hospital discharge assessed up to 30 days

    Days alive and free of mechanical ventilation

  5. Days alive and outside the intensive care unit

    Time frame: Up to hospital discharge assessed up to 30 days

    Days alive and outside the intensive care unit

  6. Hospital Mortality

    Time frame: Up to hospital discharge assessed up to 30 days

    Hospital Mortality

  7. Hemodynamics Instability

    Time frame: Up to 7 days

    Hemodynamics Instability during PEEP Titration defined as a new start of vasopressors at any dose or an increase in vasopressor dose by 20%

Other outcomes

  1. Catheter-related complications

    Time frame: 7 days

    Occurrence of esophageal catheter complications (perforation, bleeding)

Study contacts

Contact information is provided by the study sponsor or research team.

Caylin Chadwick, MSc

CONTACT

[email protected]

780.492.9951

Fernando G Zampieri, MD

CONTACT

[email protected]

780.492.9951

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: TAILOR-PEEP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.