Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-06 @ 5:00 AM
Study NCT ID:
NCT03120793
Status:
TERMINATED
Last Update Posted:
2021-01-15
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARDS Esophageal Balloon Pressure Changes With Positioning Study
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Assessing Pleural Pressure Changes Between Supine, Upright and Prone Mechanical Ventilation
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to recruit/enroll
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: