ARDS Esophageal Balloon Pressure Changes With Positioning Study

January 12, 2021 updated by: University of North Carolina, Chapel Hill

Assessing Pleural Pressure Changes Between Supine, Upright and Prone Mechanical Ventilation

The use of esophageal balloon catheters, which use esophageal pressure as a surrogate measurement for transpleural pressure, shows promise in improving outcomes of patients with severe acute respiratory distress syndrome (ARDS) requiring mechanical ventilator. The investigators hope to measure changes in in transpleural pressures in patients undergoing treatment with mechanical ventilation while switching from the supine, upright (head of bed >30 degrees), and prone positions. The goal will be to measure the changes in chest wall and lung compliance in mechanically ventilated patients with changes in position.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

The use of esophageal balloon catheters shows promise in improving outcomes of patients with severe ARDS. The estimation of pleural pressure (Ppl) has been validated in the upright position in humans with few studies commenting on the changes in supine positioning and almost none on prone positioning aside from radiographic analysis. An abstract presented at the annual American Thoracic Society meeting recently reported a series of 18 patients undergoing spinal surgery. In this population of patients without ARDS, esophageal pressure (Pes) decreased when shifting from supine to prone positioning. This suggests that transpleural pressure (PtmL) would be increased at a given airway pressure.

The investigators hope to measure changes in PtmL in patients undergoing treatment with mechanical ventilation while switching from the supine, upright (head of bed >30 degrees), and prone positions. The esophageal balloon catheter will be placed using standard techniques and secured with tape to the patients' nares during changes in positioning. The goal will be to measure the changes in chest wall and lung compliance in mechanically ventilated patients with changes in position.

Study Type

Observational

Enrollment (Actual)

2

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

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina, Chapel Hill

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be patients admitted to the medical intensive care unit with moderate to severe ARDS who are candidates for prone ventilation therapy and have no contraindications for the placement of an esophageal balloon catheter.

Description

Inclusion Criteria:

  • age at least 18 years old, need for mechanical ventilation, moderate or severe ARDS, and the ability to tolerate prone positioning.

Exclusion Criteria will be patients who:

  • are deemed too ill by their clinicians to be included in the study
  • have esophageal or nasopharyngeal pathology (such as tumors, sinusitis, epistaxis, ulcerations, recent surgery or bleeding varices) preventing insertion of the esophageal balloon catheter
  • diverticulitis
  • bronchopulmonary fistula
  • solid-organ transplantation
  • history of difficult intubation or airway management
  • or contraindications to prone positioning (per the UNC Medical Intensive Care Unit Pronation Therapy protocol, attached)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Esophageal balloon catheter placement
This is the primary and only arm of the study in which acute respiratory distress syndrome patients will have an esophageal balloon catheter placed with pressures recorded in the supine, upright and prone positions
Measurements obtained from mechanically ventilated patients with ARDS in the supine, upright and prone positions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Esophageal pressure measurements from upright to prone position
Time Frame: Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Obtained from esophageal balloon catheter measurements in prone and upright positions
Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Change in Esophageal pressure measurements from upright to supine position
Time Frame: The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.
Obtained from esophageal balloon catheter measurements in upright and supine positions
The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Transmural pressure measurements from upright to prone position
Time Frame: Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Obtained from combination of esophageal balloon catheter measurements and mechanical ventilator in upright and prone positions
Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Change in Transmural pressure measurements from upright to supine position
Time Frame: The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.
Obtained from esophageal balloon catheter measurements in upright and supine positions
The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.
Change in Airway pressure measurements from upright to prone position
Time Frame: Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Obtained from mechanical ventilator in prone and upright positions
Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.
Change in Airway pressure measurements from upright to supine position
Time Frame: The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.
Obtained from mechanical ventilator in supine and upright positions
The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Thomas Bice, MD, MS, UNC Pulmonology and Critical Care

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 (Actual)

May 11, 2017

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (Actual)

April 19, 2017

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 17-0135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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