Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-05 @ 6:37 PM
Study NCT ID:
NCT03567759
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2018-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transpulmonary Pressure in One Lung Ventilation and Open Pneumothorax
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2018-06-13', 'studyFirstSubmitQcDate': '2018-06-13', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in esophageal pressure', 'timeFrame': 'from tracheal intubation untill fiveminutes after induction of open pneumothorax', 'description': 'esophageal pressure in supine and lateral positions, and following one lung ventilation and open pneumothorax'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumothorax']}, 'descriptionModule': {'briefSummary': 'Esophageal Pressure During one lung ventilation', 'detailedDescription': 'Esophageal pressure comparison during positive pressure ventilation, one lung ventilation, lateral position and open pneumothorax'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients of age 18-85 years scheduled for VATS requiring one lung ventilation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for VATS requiring one lung ventilation\n* Body mass index below 35 kg/m\\^2\n\nExclusion Criteria:\n\n* esophageal pathology preventing insertion of orogatric tube\n* scoliosys'}, 'identificationModule': {'nctId': 'NCT03567759', 'briefTitle': 'Transpulmonary Pressure in One Lung Ventilation and Open Pneumothorax', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Effect 0ne Lung Ventilation and Open Pneumothorax on Respiratory Mechanics and Transpulmonary Pressure', 'orgStudyIdInfo': {'id': 'RMB 15-0262'}}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Amit Lehavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Pediatric Anesthesia', 'investigatorFullName': 'Dr. Amit Lehavi MD FANZCA', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}