Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obesity Morbid
- Respiratory Failure
- Ventilator Induced Lung Injury
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: Due to the obvious treatment differences between the two groups, blinding of treatment group will be impossible. However, the investigators will have one outcome assessor who will have access only to the data necessary to determine the primary outcome (Ventilator-Free Days at 28-days), and this assessor will be blinded to treatment group using built-in REDCap tools.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Study Design: Randomized-controlled clinical trial. Patients will be enrolled within 4 days of mechanical ventilation and randomized 1:1 to titration of PEEP based on esophageal balloon pressures or based on the "High PEEP" ARDSnet PEEP/FiO2 (fraction of inspired oxygen) table. All patients will hav...
Study Design: Randomized-controlled clinical trial. Patients will be enrolled within 4 days of mechanical ventilation and randomized 1:1 to titration of PEEP based on esophageal balloon pressures or based on the "High PEEP" ARDSnet PEEP/FiO2 (fraction of inspired oxygen) table. All patients will have esophageal balloons placed with baseline measurement of Ptp. Patients randomized to the intervention arm will then undergo titration of PEEP based on Ptp measurements to achieve "Optimal PEEP," defined as end expiratory Ptp of 0 to +2 cm H2O.
Tracking Information
- NCT #
- NCT03951064
- Collaborators
- East Carolina University
- Investigators
- Principal Investigator: Thomas Bice, MD University of North Carolina, Chapel Hill Principal Investigator: Shannon Carson, MD University of North Carolina, Chapel Hill
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