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Clinical Trials/NCT03120793
NCT03120793
Terminated
Not Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country2 target enrollmentMay 11, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS
Sponsor
University of North Carolina, Chapel Hill
Enrollment
2
Locations
1
Primary Endpoint
Change in Esophageal pressure measurements from upright to supine position
Status
Terminated
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2017
End Date
March 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Change in Transmural pressure measurements from upright to prone position(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(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(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(The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.)

Study Sites (1)

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