ARDS Esophageal Balloon Pressure Changes With Positioning Study
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Change in Esophageal 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.]
Obtained from esophageal balloon catheter measurements in prone and upright positions
- Change in Esophageal 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.]
Obtained from esophageal balloon catheter measurements in upright and supine positions
Secondary Outcome Measures
- 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.]
Obtained from combination of esophageal balloon catheter measurements and mechanical ventilator in upright and prone positions
- 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.]
Obtained from esophageal balloon catheter measurements in upright and supine positions
- 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.]
Obtained from mechanical ventilator in prone and upright positions
- 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.]
Obtained from mechanical ventilator in supine and upright positions
Eligibility Criteria
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:
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are deemed too ill by their clinicians to be included in the study
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have esophageal or nasopharyngeal pathology (such as tumors, sinusitis, epistaxis, ulcerations, recent surgery or bleeding varices) preventing insertion of the esophageal balloon catheter
-
diverticulitis
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bronchopulmonary fistula
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solid-organ transplantation
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history of difficult intubation or airway management
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or contraindications to prone positioning (per the UNC Medical Intensive Care Unit Pronation Therapy protocol, attached)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | United States | 27514 |
Sponsors and Collaborators
- University of North Carolina, Chapel Hill
Investigators
- Principal Investigator: Thomas Bice, MD, MS, UNC Pulmonology and Critical Care
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-0135