Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients (TAILOR-PEEP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: Esophageal pressure-guided PEEP titration; Other: Standard care PEEP management

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fernando G Zampieri, MD; Phone Number: 780.492.9951; Email: fzampier@ualberta.ca
• Study Contact Backup: Name: Caylin Chadwick, MSc; Phone Number: 780.492.9951; Email: Caylin.Chadwick@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • Recruiting
      • University of Alberta Hospital
      • Contact: Fernando G Zampieri, MD; Phone Number: 780.492.9951; Email: fzampier@ualberta.ca
    • St. Albert, Alberta, Canada
      • Recruiting
      • Sturgeon Community Hospital
      • Contact: Oleksa Rewa, MD; Phone Number: 780.492.995; Email: rewa@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esophageal-balloon guided; 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; 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
Active Comparator: Standard of Care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average PEEP	Key secondary endpoint. Mean positive end-expiratory pressure during mechanical ventilation	7 days
Driving Pressure	Difference in driving pressure between groups	7 days
Partial oxygen pressure over inspired oxygen fraction ratio	P/F ratio	7 days
Days alive and free of mechanical ventilation	Days alive and free of mechanical ventilation	Up to hospital discharge assessed up to 30 days
Days alive and outside the intensive care unit	Days alive and outside the intensive care unit	Up to hospital discharge assessed up to 30 days
Hospital Mortality	Hospital Mortality	Up to hospital discharge assessed up to 30 days
Hemodynamics Instability	Hemodynamics Instability during PEEP Titration defined as a new start of vasopressors at any dose or an increase in vasopressor dose by 20%	Up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter-related complications	Occurrence of esophageal catheter complications (perforation, bleeding)	7 days

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mechanical ventilation; obesity; PEEP
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Respiratory Tract Diseases; Respiration Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Respiratory Insufficiency
• Other Study ID Numbers: Pro00154874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No