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ARDS Esophageal Balloon Pressure Changes With Positioning Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03120793
Recruitment Status : Terminated (Failure to recruit/enroll)
First Posted : April 19, 2017
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Bice, MD, MSc, University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment
ARDS Respiratory Failure Device: Esophageal balloon catheter

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.

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Pleural Pressure Changes Between Supine, Upright and Prone Mechanical Ventilation
Actual Study Start Date : May 11, 2017
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020

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
Device: Esophageal balloon catheter
Measurements obtained from mechanically ventilated patients with ARDS in the supine, upright and prone positions




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120793


Locations
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United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Thomas Bice, MD, MS UNC Pulmonology and Critical Care
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Responsible Party: Thomas Bice, MD, MSc, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03120793    
Other Study ID Numbers: 17-0135
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases