Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

NCT07359261 | Recruiting Phase 2 DMC

• 1 other identifier: Pro00154874
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Respiratory Failure

Keywords

PEEP; obesity; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Feasibility of conducting a definitive trial (composite)

  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.

  14 months

Secondary Outcomes (7)

• Average PEEP

  7 days

• Driving Pressure

  7 days

• Partial oxygen pressure over inspired oxygen fraction ratio

  7 days

• Days alive and free of mechanical ventilation

  Up to hospital discharge assessed up to 30 days

• Days alive and outside the intensive care unit

  Up to hospital discharge assessed up to 30 days

Other Outcomes (1)

• Catheter-related complications

  7 days

Study Arms (2)

Esophageal-balloon guided

EXPERIMENTAL

Esophageal balloon catheter placed within 4 hours of randomization. PEEP titrated to achieve end-expiratory transpulmonary pressure of 0-2 cmH2O (up to 8 cmH2O for P/F ratio \<200). PEEP adjusted in 2 cmH2O increments with 5-minute stabilization periods. Safety limits: transpulmonary driving pressure \<15 cmH2O, end-inspiratory transpulmonary pressure \<20 cmH2O. Reassessment twice daily (approximately 0800 and 2200). Catheter removed prior to extubation or at 28 days, whichever occurs first.

Procedure: Esophageal pressure-guided PEEP titration

Standard of Care

ACTIVE COMPARATOR

PEEP management according to current standard practice. For patients meeting ARDS criteria, PEEP titrated using the ARDSNet PEEP/FiO2 table. For non-ARDS patients, PEEP titrated per local practice to optimize oxygenation while monitoring hemodynamic tolerance and respiratory mechanics. No esophageal pressure monitoring.

Other: Standard care PEEP management

Interventions

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.

Also known as: Transpulmonary pressure-guided PEEP titration, Pes-guided PEEP management

Esophageal-balloon guided

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, Canada

RECRUITING

Sturgeon Community Hospital

St. Albert, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Fernando G Zampieri, MD

CONTACT

780.492.9951; fzampier@ualberta.ca

Caylin Chadwick, MSc

CONTACT

780.492.9951; Caylin.Chadwick@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 22, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: Anonymized data may be shared after discussion with study steering committee, approval from ethics from University of Alberta, and establishment of data sharing agreement.

Locations

CA (2)