Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-01-02 @ 1:59 PM
Study NCT ID:
NCT02949856
Status:
UNKNOWN
Last Update Posted:
2016-10-31
First Post:
2016-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in intracuff pressure', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Change in distance from carina to tip of tube', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thyroidectomy']}, 'descriptionModule': {'briefSummary': 'This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.\n\nFifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy\n\nExclusion Criteria:\n\n* difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity'}, 'identificationModule': {'nctId': 'NCT02949856', 'briefTitle': 'E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck', 'organization': {'class': 'OTHER', 'fullName': 'Keimyung University Dongsan Medical Center'}, 'officialTitle': 'Endotracheal Tube Intracuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck - Comparison of a Tapered Shaped- and Cylindrical Shaped Cuff', 'orgStudyIdInfo': {'id': '2016-05-032-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tapered', 'description': 'Mallinckrodt, COVIDIEN', 'interventionNames': ['Device: Mallinckrodt, COVIDIEN']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cylindrical', 'description': 'Endotracheal tube, Unomedical', 'interventionNames': ['Device: Endotracheal tube, Unomedica']}], 'interventions': [{'name': 'Mallinckrodt, COVIDIEN', 'type': 'DEVICE', 'armGroupLabels': ['Tapered']}, {'name': 'Endotracheal tube, Unomedica', 'type': 'DEVICE', 'armGroupLabels': ['Cylindrical']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yong-Cheol Lee, MD, PhD', 'role': 'CONTACT', 'email': 'yclee@dsmc.or.kr', 'phone': '82-53-250-7193'}], 'overallOfficials': [{'name': 'Yong-Cheol Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyung University Dongsan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}