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

University of Alberta

Status and phase: Not yet enrolling; Phase 2

Conditions: Respiratory Failure

Treatments: Other: Standard care PEEP management; Procedure: Esophageal pressure-guided PEEP titration

Study type: Interventional

Funder types: Other

Identifiers

NCT07359261

Pro00154874

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Esophageal-balloon guided

Experimental group

Description:

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.

Treatment:

Procedure: Esophageal pressure-guided PEEP titration

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard care PEEP management