Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-27 @ 6:35 PM
Study NCT ID:
NCT05093595
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2021-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of Trans-nasal Fixation of Endotracheal Tubes for Prone Ventilation
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-05', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the distance of tube movement', 'timeFrame': 'The participants will be followed from intubation to extubation, an expected average of 6 hours.', 'description': 'It is the difference between the preoperative depth of the supine tracheal tube and the postoperative depth of the prone tracheal tube.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prone Craniotomy', 'Endotracheal Intubation Fixation']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled trial is to evaluate the clinical effects of trans-nasal ETT fixation for prone ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* age 18-60 years old,\n* ASA grade Ⅰ-Ⅱ,\n* 18\\<BMI\\<24.\n\nExclusion criteria\n\n* the intubation time was less than 5 hours,\n* oral and facial skin damage,\n* allergic to adhensive tapes,\n* nasotracheal intubation,\n* patients were edentulous.'}, 'identificationModule': {'nctId': 'NCT05093595', 'acronym': 'Trans', 'briefTitle': 'the Effect of Trans-nasal Fixation of Endotracheal Tubes for Prone Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'Trans-nasal ETT Fixation', 'orgStudyIdInfo': {'id': '2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A', 'description': 'The tracheal tube was routinely fixed with a teeth pad and adhesive tape (3M).'}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'The tracheal tube was fixed by the trans-nasal Silicone Foley Catheter (SFC) and adhesive tape.', 'interventionNames': ['Device: SFC']}], 'interventions': [{'name': 'SFC', 'type': 'DEVICE', 'description': 'The lubricated SFC passed nasally into the oropharynx under the visual guidance of visual laryngoscope to ensure that the cuff had passed through the posterior choanae and reached the oropharynx. The guide wire is removed and the balloon inflated with 5 ml normal saline. The catheter is then pulled slightly until the balloon is fixed and concealed by the soft palate . The ETT is anchored to the SFC with a cable tie .', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Yue Yun', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Doctor', 'investigatorFullName': 'Yue Yun', 'investigatorAffiliation': 'China Medical University, China'}}}}