Transpulmonary Assessment for Individualized Lung Optimization in Obese Patients

ConditionRespiratory Failure

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Body mass index ≥30 kg/m²

Intubated and receiving passive mechanical ventilation

Within 24 hours of intubation

Disqualifiers

Known or suspected esophageal varices

Esophageal surgery within 3 months

Known esophageal stricture or perforation

Active upper gastrointestinal bleeding

Trial design

Design model

Parallel

Treatments tested in this trial

Esophageal pressure-guided PEEP titration
Procedure/Surgery
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.
Standard care PEEP management
Other intervention
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Esophageal-balloon guidedExperimental treatment 1 intervention

Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

14 months

Secondary outcomes

Average PEEP

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

Time frame

7 days

Driving Pressure

Difference in driving pressure between groups

Time frame

7 days

Partial oxygen pressure over inspired oxygen fraction ratio

P/F ratio

Time frame

7 days

Days alive and free of mechanical ventilation

Time frame

Up to hospital discharge assessed up to 30 days

Other outcomes

Catheter-related complications

Occurrence of esophageal catheter complications (perforation, bleeding)

Time frame

7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov

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