- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03120793
ARDS Esophageal Balloon Pressure Changes With Positioning Study
Assessing Pleural Pressure Changes Between Supine, Upright and Prone Mechanical Ventilation
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- University of North Carolina, Chapel Hill
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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
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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.
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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
Investigators
- Principal Investigator: Thomas Bice, MD, MS, UNC Pulmonology and Critical Care
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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