Esophageal Balloon Guided Weaning of the Morbidly Obese Patient

December 17, 2014 updated by: Ogugua N Obi, MD, MPH, East Carolina University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Vidant Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Esophageal balloon Arm
Patients in this arm were randomly assigned to have their PEEP adjusted to maintain a positive transpulmonary pressure (0 to 10 cm H20).
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.
Active Comparator: Cstat Arm
Patients in this arm had their PEEP adjusted to achieve the best static effective compliance (CStat).
Other: Cstat
PEEP was adjusted to achieve the best CStat in this group of patients
No Intervention: Historic Controls
These were historic controls with similar patient characteristics weaned by traditional methods in the 2-year period prior to the start of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients weaned by day 30
Time Frame: 30-days
A patient was considered successfully weaned and "ventilator independent" if they were spontaneously breathing without ventilator support for at least 24 hours, and remained off the ventilator by day 30. If ventilator support was subsequently required, the patient was returned to their original group and considered not weaned. The patients were considered to be weaned or not, after a period of thirty days.
30-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to wean
Time Frame: 30-days
The time to wean/ time to achieve ventilator independence was measured from the date of randomization to the date of final successful liberation from mechanical ventilation. If patient had an unsuccessful initial wean, he was not considered weaned. Only patients who were considered weaned by day 30 accrued "time to ventilator independence."
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Investigators

  • Principal Investigator: Robert Shaw, MD, East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol 10-0343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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