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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Failure to recruit/enroll', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Esophageal pressure measurements from upright to prone position', 'timeFrame': 'Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.', 'description': 'Obtained from esophageal balloon catheter measurements in prone and upright positions'}, {'measure': 'Change in Esophageal pressure measurements from upright to supine position', 'timeFrame': 'The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.', 'description': 'Obtained from esophageal balloon catheter measurements in upright and supine positions'}], 'secondaryOutcomes': [{'measure': 'Change in Transmural pressure measurements from upright to prone position', 'timeFrame': 'Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.', 'description': 'Obtained from combination of esophageal balloon catheter measurements and mechanical ventilator in upright and prone positions'}, {'measure': 'Change in Transmural pressure measurements from upright to supine position', 'timeFrame': 'The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.', 'description': 'Obtained from esophageal balloon catheter measurements in upright and supine positions'}, {'measure': 'Change in Airway pressure measurements from upright to prone position', 'timeFrame': 'Measurements will be obtained in the baseline upright position and repeated after about 4 hours in the prone position.', 'description': 'Obtained from mechanical ventilator in prone and upright positions'}, {'measure': 'Change in Airway pressure measurements from upright to supine position', 'timeFrame': 'The patient is upright at baseline where measurements will be obtained. About 5 minutes will be spent in the supine position.', 'description': 'Obtained from mechanical ventilator in supine and upright positions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['ARDS', 'Respiratory Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age at least 18 years old, need for mechanical ventilation, moderate or severe ARDS, and the ability to tolerate prone positioning.\n\nExclusion Criteria will be patients who:\n\n* are deemed too ill by their clinicians to be included in the study\n* have esophageal or nasopharyngeal pathology (such as tumors, sinusitis, epistaxis, ulcerations, recent surgery or bleeding varices) preventing insertion of the esophageal balloon catheter\n* diverticulitis\n* bronchopulmonary fistula\n* solid-organ transplantation\n* history of difficult intubation or airway management\n* or contraindications to prone positioning (per the UNC Medical Intensive Care Unit Pronation Therapy protocol, attached)'}, 'identificationModule': {'nctId': 'NCT03120793', 'briefTitle': 'ARDS Esophageal Balloon Pressure Changes With Positioning Study', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Assessing Pleural Pressure Changes Between Supine, Upright and Prone Mechanical Ventilation', 'orgStudyIdInfo': {'id': '17-0135'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Esophageal balloon catheter placement', 'description': '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', 'interventionNames': ['Device: Esophageal balloon catheter']}], 'interventions': [{'name': 'Esophageal balloon catheter', 'type': 'DEVICE', 'description': 'Measurements obtained from mechanically ventilated patients with ARDS in the supine, upright and prone positions', 'armGroupLabels': ['Esophageal balloon catheter placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Thomas Bice, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Pulmonology and Critical Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}