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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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.
University of Alberta Hospital
Edmonton, Alberta, Canada
RECRUITINGSturgeon Community Hospital
St. Albert, Alberta, Canada
RECRUITINGFeasibility 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
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
Days alive and free of mechanical ventilation
Time frame: 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
Time frame: Up to hospital discharge assessed up to 30 days
Hospital Mortality
Hospital Mortality
Time frame: 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%
Time frame: Up to 7 days
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