Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Morbid
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Number of Ventilator-Free Days (VFD) by Day 28
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator.
Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.
Detailed 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/fraction of inspired oxygen (FiO2) 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 water (H2O).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index greater than or equal to 40
- •Acute respiratory failure requiring mechanical ventilation
Exclusion Criteria
- •Refusal to give consent by the subject or their legally authorized representative
- •Abdominal compartment syndrome
- •Chest tube for pneumothorax
- •Having been on a ventilator for \>4 days
- •Suspicion of or known intracranial hypertension
- •Anticipated extubation within 24 hours
- •Chronic ventilator dependence
- •Condition that precludes placement of an esophageal balloon (esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter, severe thrombocytopenia or coagulopathy)
- •Incarceration
Outcomes
Primary Outcomes
Number of Ventilator-Free Days (VFD) by Day 28
Time Frame: 28 days
The number of days a patient is alive and free from the ventilator up to day 28.
Secondary Outcomes
- ICU Length of Stay(maximum duration of ICU stay, up to 46 days)
- Number of Patients Receiving a Tracheostomy(during mechanical ventilation, up to 28 days)
- Number of Participants Reintubated(72 hours after extubation)
- Lowest Richmond Agitation and Sedation Scale(during mechanical ventilation, up to 28 days)
- Hospital Length of Stay(maximum duration of hospital stay, up to 83 days)
- Number of Patients Extubated Early(28 days)
- Highest Richmond Agitation and Sedation Scale(during mechanical ventilation, up to 28 days)