Effects of Different PEEP Levels on Work of Breathing in Morbidly Obese Patients Prior to and After Extubation

Last updated: February 18, 2026
Sponsor: Massachusetts General Hospital
Overall Status: Trial Not Available

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

ZEEP

Positive end-expiratory pressure (PEEP)

Clinical Study ID

NCT02492113
WOBTRIAL
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to define at the bedside the "Titrated-PEEP" level for obese patients that increases the likelihood of extubation and ventilator liberation.

The investigators hypothesized that a titrated level of PEEP ("Titrated-PEEP") during SBT will keep the lung recruited, maintain oxygenation, and decrease the work of breathing resulting in successful ventilator liberation. In addition, post-extubation the investigators hypothesize that these patients will require noninvasive ventilatory support in the form of CPAP at the level of "titrated-PEEP" used during the SBT.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Intubated and mechanically ventilated;

  • Weaning from mechanical ventilation;

  • BMI ≥ 35 kg/m2 with waist circumference > 88 cm for women; waist circumference > 102cm for men.

  • A well functioning arterial line.

Exclusion

Exclusion Criteria:

  • Known presence of esophageal varices

  • Recent esophageal trauma or surgery

  • Severe thrombocytopenia (PTL ≤ 5,000/mm3)

  • Severe coagulopathy (INR ≥ 4)

  • Presence of pneumothorax

  • Pregnancy

  • Pacemaker and/or internal cardiac defibrillator

Study Design

Treatment Group(s): 2
Primary Treatment: ZEEP
Phase:
Study Start date:
November 01, 2015
Estimated Completion Date:
November 24, 2025

Study Description

The high WOB of morbidly obese patients is associated with respiratory muscle fatigue and failure in extubation. The investigators hypothesized that the use of a titrated PEEP level prior to and after extubation might improve successful extubation rates and avoid re-intubation.

In this study, patients will be awake and ventilated in the pressure support ventilation (PSV) mode. The investigators will apply different PEEP levels to measure WOB, transpulmonary pressure and characterize the response of the respiratory system to increasing or decreasing PEEP. The "Titrated-PEEP" will be identified as the PEEP level associated with the lowest value of respiratory system elastance and an end expiratory transpulmonary pressure of 2 cmH2O. Then the participants will have two spontaneous breathing trials; one at PEEP 0-5 cmH2O, and the other at the "Titrated-PEEP" level, with PSV=0 and FiO2 unchanged. After extubation, the participants will first receive CPAP set at "Titrated-PEEP", then spontaneous breathing. Electrical impedance tomography (EIT), respiratory system mechanics and gas exchange will be recorded during the study.

The investigators believe that the real-time determination of "Titrated-PEEP" can guide the treatment of mechanical ventilation and give us a better understanding of the physiology and pathophysiology of morbidly obese patients. As a result, this study will improve patient safety; reduce the duration of mechanical ventilation, complications and healthcare costs.

Connect with a study center

  • Massachussets General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachussets General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

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