Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon

Not Applicable

Terminated

Conditions: Obesity, Morbid
Ventilator-Induced Lung Injury
Respiratory Failure

Registration Number: NCT03951064

Lead Sponsor: University of North Carolina, Chapel Hill

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).

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Ventilator-Free Days (VFD) by Day 28	28 days	The number of days a patient is alive and free from the ventilator up to day 28.

Secondary Outcome Measures

Name	Time	Method
ICU Length of Stay	maximum duration of ICU stay, up to 46 days	Number of days spent in the ICU
Number of Patients Receiving a Tracheostomy	during mechanical ventilation, up to 28 days	Whether the patient required a tracheostomy to be liberated from the ventilator
Number of Participants Reintubated	72 hours after extubation	Intubated within 72 hours of extubation
Lowest Richmond Agitation and Sedation Scale	during mechanical ventilation, up to 28 days	Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the lowest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome.
Hospital Length of Stay	maximum duration of hospital stay, up to 83 days	Number of days spent in the Hospital
Number of Patients Extubated Early	28 days	Extubation prior to meeting established criteria (Control group only). Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking.
Highest Richmond Agitation and Sedation Scale	during mechanical ventilation, up to 28 days	Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the highest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome.

Trial Locations

Locations (2): University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
East Carolina University
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Greenville, North Carolina, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States