Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02901158
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esophageal Manometry in Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Esophageal pressure measurements in mechanically ventilated patients', 'timeFrame': 'Within one hour', 'description': 'Esophageal pressure was measured in mechanically ventilated patients in the critical care unit and in the operating room.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['esophageal pressure', 'chest wall elastance', 'lung elastance', 'transpulmonary pressure'], 'conditions': ['Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '31196203', 'type': 'DERIVED', 'citation': 'Persson P, Ahlstrand R, Gudmundsson M, de Leon A, Lundin S. Detailed measurements of oesophageal pressure during mechanical ventilation with an advanced high-resolution manometry catheter. Crit Care. 2019 Jun 13;23(1):217. doi: 10.1186/s13054-019-2484-8.'}]}, 'descriptionModule': {'briefSummary': 'Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure.\n\nIn this study high resolution solid-state manometry technique was used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure.', 'detailedDescription': 'Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure.\n\nIn this study high resolution solid-state manometry technique was instead used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. The manometry catheter has 36 circumferential sensors at 1 cm intervals. Each sensor has 12 pressure-sensitive segments that add to the signal at that location. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure. Possible differences in tidal variations in esophageal pressure in different parts of the esophagus were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mechanically ventilated patients in the critical care unit and in the operating room.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the critical care unit receiving mechanical ventilation or Patients anesthetized and undergoing surgery\n\nExclusion Criteria:\n\n* Patients with a contraindication to insert a catheter in the esophagus for instance due to an operation.'}, 'identificationModule': {'nctId': 'NCT02901158', 'briefTitle': 'Esophageal Manometry in Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Esophageal Manometry in Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': 'LUA-74203'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critical care patients', 'description': 'Mechanically ventilated patients in the critical care unit'}, {'label': 'OR-patients', 'description': 'Mechanically ventilated patients in the operating room'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Stefan Lundin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stefan Lundin', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}