Esophageal Balloon Guided Weaning of the Morbidly Obese Patient

Stopped early · Not applicable

Conditions studied: Morbid Obesity

In brief

This is a study to evaluate whether PEEP adjusted by use of an esophageal balloon to overcome negative transpulmonary pressure; or adjusted by use of "CStat" to achieve the best effective static compliance will have any effect on outcomes with respect to ventilator weaning in tracheotomized morbidly obese patients (BMI \>=40) with at least one failed prior weaning attempt.

Key facts

Study ID: NCT02323009
Run by: East Carolina University
People needed: 25
Starts: 2011-01-01
Expected to finish: 2013-11-01
Last updated by the study team: 2014-12-23

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Morbidly obese patients with BMI of 40 or greater
Ventilator dependent patients (defined as at least one prior failure at weaning)
Tracheotomized
No active underlying lung disease that would preclude ventilator weaning
Stable hemodynamics
Patient/ family able to give consent
No naso-facial abnormalities that would interfere with placement of an esophageal balloon
Fio2 <= 60%
Patient able to tolerate Pressure Support ventilation

You may not qualify if…

Lack of consent
Patient deemed not weanable from mechanical ventilation as per the clinical judgement of the pulmonary physician
Significant lung, heart or neuromuscular disease that would interfere with or preclude ventilator weaning, including an active ongoing lung infection.
Contraindications to placement of an esophageal pressure monitoring device - such as ulcerations, tumors, diverticulitis, uncontrolled bleeding varices, sinusitis, epistaxis or recent nasopharyngeal surgery

Where it is running

Vidant Medical Center — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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