NCT02323009

Esophageal Balloon Guided Weaning of the Morbidly Obese Patient

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: East Carolina University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Tracheotomized morbidly obese patients (BMI \>= 40) who had failed an initial attempt at ventilator weaning (defined in the investigators study as ventilator dependent) were randomly assigned to one of two methods for setting Positive End Expiratory Pressure (PEEP). Patients randomized to the esophageal balloon arm (ESO group) had their PEEP adjusted to overcome negative transpulmonary pressure and maintain a positive transpulmonary pressure (Ptp) of 0 to 10 cm H20 - targeting as close to zero as possible. Patients randomized to the static effective compliance arm (CStat group) had their PEEP adjusted to achieve the best static effective compliance as automatically calculated and displayed on the graphic interphase of the hamilton G5 or Galileo ventilator. For this group, the PEEP was adjusted in increments of 3 cm H20 until there was a less than 5% observed improvement in the static effective compliance. the PEEP with the best Cstat was chosen. At the end of the intervention period, this intervention cohort (termed "PEEP intervention cohort") will be compared to a group of historical controls to compare the efficiency of a PEEP-based weaning protocol to traditional weaning methods. The investigators hypothesized that PEEP levels titrated by use of an esophageal balloon to maintain a positive transpulmonary pressure between 0 to 10 cm H20, would lead to improved outcomes with respect to ventilator weaning in this subset of patients.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
DEVICE	Esophageal Balloon	Esophageal balloon was used to measure esophageal pressure (Paux) which was used as an estimate of pleural pressure. Transpulmonary pressure (Ptp) was calculated as the difference between airway pressure (Pao) and Paux. Applied PEEP was then adjusted to overcome negative Ptp which we maintained between 0 to 10 cm H20. All measurements were made at end-expiration.
OTHER	Cstat	PEEP was adjusted to achieve the best CStat in this group of patients

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2014-12-23
• Last updated: 2014-12-23

Locations

1 site across 1 country: United States