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

Last updated: June 4, 2024
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Terminated

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

Intervention Weaning after Tracheostomy

Control Spontaneous Breathing Trial and Extubation

Control Weaning after Tracheostomy

Clinical Study ID

NCT03951064
18-2010
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index greater than or equal to 40

  • Acute respiratory failure requiring mechanical ventilation

Exclusion

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 ornasopharyngeal pathology preventing insertion of the esophageal balloon catheter,severe thrombocytopenia or coagulopathy)

  • Incarceration

Study Design

Total Participants: 6
Treatment Group(s): 5
Primary Treatment: Intervention Weaning after Tracheostomy
Phase:
Study Start date:
March 31, 2021
Estimated Completion Date:
December 06, 2022

Study 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).

Connect with a study center

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Site Not Available

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