Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT01384318
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2011-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accuracy of Using the CPAP Technique to Eliminate Air Leak and Prevent Excessive Endotracheal Tube Cuff Pressures
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': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2011-06-27', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cuff pressure', 'timeFrame': 'Baseline', 'description': 'cm H2O measured by manometer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgical Patients Intubated With Cuffed ETT']}, 'referencesModule': {'references': [{'pmid': '20560884', 'type': 'BACKGROUND', 'citation': 'Eschertzhuber S, Salgo B, Schmitz A, Roth W, Frotzler A, Keller CH, Gerber AC, Weiss M. Cuffed endotracheal tubes in children reduce sevoflurane and medical gas consumption and related costs. Acta Anaesthesiol Scand. 2010 Aug;54(7):855-8. doi: 10.1111/j.1399-6576.2010.02261.x. Epub 2010 Jun 15.'}, {'pmid': '19887533', 'type': 'BACKGROUND', 'citation': 'Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.'}, {'pmid': '17187473', 'type': 'BACKGROUND', 'citation': 'Weiss M, Dullenkopf A. Cuffed tracheal tubes in children: past, present and future. Expert Rev Med Devices. 2007 Jan;4(1):73-82. doi: 10.1586/17434440.4.1.73.'}]}, 'descriptionModule': {'briefSummary': 'In common clinical practice, one means of ensuring an acceptable cuff pressure in endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of this study is to validate this technique by checking the intracuff pressure using a manometer after the cuff is inflated using the CPAP technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients intubated with cuffed ETTs.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a cuffed ETT placed per treating anesthesiologist\n* \\< 18 yrs of age.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01384318', 'briefTitle': 'Accuracy of Using the CPAP Technique to Eliminate Air Leak and Prevent Excessive Endotracheal Tube Cuff Pressures', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB11-00414'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cuffed ETT', 'description': 'Patients intubated with cuffed endotracheal tubes.', 'interventionNames': ['Other: Manometer']}], 'interventions': [{'name': 'Manometer', 'type': 'OTHER', 'description': 'Measuring cuff pressure', 'armGroupLabels': ['Cuffed ETT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Joseph D Tobias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman Dept. of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}