Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT01533012
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2012-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2012-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2012-02-07', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fiberoptic bronchoscopy view', 'timeFrame': 'within 5 min after intubation', 'description': '1. aucsultation under manual ventilation -\\> fiberopric bronchoscopy view check\n2. peak inspiratory pressure difference under mechanical ventilation -\\> fiberoptic bronchoscopy view check'}], 'secondaryOutcomes': [{'measure': 'depth of double lumen tube', 'timeFrame': 'within 5 min after checking fiberopitics', 'description': '1. aucsultation under manual ventilation -\\> A depth of DLT (incisor)\n2. peak inspiratory pressure difference under mechanical ventilation -\\> A depth of DLT (incisor)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thoracic Surgery']}, 'referencesModule': {'references': [{'pmid': '24047768', 'type': 'DERIVED', 'citation': 'Kim SH, Choi YS, Shin S, Cho JS, Nam DJ, Oh YJ. Positioning of double-lumen tubes based on the minimum peak inspiratory pressure difference between the right and left lungs in short patients: a prospective observational study. Eur J Anaesthesiol. 2014 Mar;31(3):137-42. doi: 10.1097/EJA.0b013e328364c3a7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate a performance of initial positioning of left sided double lumen endobronchial tubes using peak inspiratory pressures difference between two lungs.', 'detailedDescription': 'If both lungs have relatively equal volumes and the double lumen tube is in a satisfactory position, peak inspiratory pressure between two lungs is similar or equal when each lumen is sequentially clamped while ventilating each lung with the same tidal volume. We are going to investigate a performance of this method by fiberoptic bronchoscopy view and depth of double lumen tube, and compare with an conventional auscultation method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status class I, II\n* Use of double lumen tube\n* Normal preoperative pulmonary function study\n\nExclusion Criteria:\n\n* COPD\n* Restrictive lung disease\n* CAOD\n* Unstable hemodynamic status\n* Peak inspiratory pressure \\> 30 mm Hg (Two lung ventilation)'}, 'identificationModule': {'nctId': 'NCT01533012', 'briefTitle': 'Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Initial Positioning of Left Sided Double Lumen Endobronchial Tubes Using Peak Inspiratory Pressures Difference Between Two Lungs', 'orgStudyIdInfo': {'id': '4-2011-0619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pressure difference', 'description': 'Peak inspiratory pressures difference between two lungs', 'interventionNames': ['Procedure: Pressure difference']}, {'type': 'NO_INTERVENTION', 'label': 'FOB evaluation', 'description': 'FOB evaluation for the optimal position of tubes'}], 'interventions': [{'name': 'Pressure difference', 'type': 'PROCEDURE', 'description': 'Peak inspiratory pressures difference between two lungs', 'armGroupLabels': ['Pressure difference']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}