Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT03289767
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2017-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simple Preparation of Endotracheal Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2017-09-18', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful intubation on first attempt', 'timeFrame': 'On endotracheal intubation up to 1 min', 'description': 'Whether successful intubation is done on first attempt or on additional attempt'}], 'secondaryOutcomes': [{'measure': 'Time to intubate (TIT)', 'timeFrame': 'On endotracheal intubation up to 1 min', 'description': 'The TIT started when the blade first passed the lips, and ended when the the detection of end-tidal CO2 trace'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endotracheal Tube']}, 'descriptionModule': {'briefSummary': 'To observe the effect of additional E-tube angulation on intubation time and success rate.', 'detailedDescription': 'The hypothesis of this study is that shaping endotracheal tube by end-to-end connection before induction will provide more optimal angulation for endotracheal intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients scheduled for elective surgery requiring general anesthesia and tracheal intubation\n\nExclusion Criteria:\n\n* Patients with congenital or acquired upper airway lesions\n* Patients with high risk of aspiration'}, 'identificationModule': {'nctId': 'NCT03289767', 'briefTitle': 'Simple Preparation of Endotracheal Tube', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Simple Preparation of Endotracheal Tube for Optimal Angulation During Intubation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'JHSeo_angulation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Curved-tube', 'description': 'Giving additional curve to the endotracheal tube by simple preparation.', 'interventionNames': ['Other: Curved-tube']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No other manipulation of the endotracheal tube is done.'}], 'interventions': [{'name': 'Curved-tube', 'type': 'OTHER', 'description': 'Connecting both ends of the endotracheal tube ("O" shape) for 5-min and releasing it provides additional anterior angle temporarily.', 'armGroupLabels': ['Curved-tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong-Hwa Seo, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong-Hwa Seo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}