Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05739318
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2023-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Diameter of Double-lumen Tube Measured by Different Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-29', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-02-18', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of complications', 'timeFrame': '12 weeks', 'description': 'Incidence of postoperative hoarseness and throat pain in patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Therapeutic Procedural Complication']}, 'referencesModule': {'references': [{'pmid': '39080380', 'type': 'DERIVED', 'citation': 'Cui G, Zhao L, Chi C, Liang S, Liu Z. The feasibility and accuracy of the method for selecting the optimal size of double-lumen tube in thoracic surgery: a prospective, randomized controlled trial. Sci Rep. 2024 Jul 30;14(1):17539. doi: 10.1038/s41598-024-68349-z.'}]}, 'descriptionModule': {'briefSummary': 'The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.', 'detailedDescription': 'The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia\n\nExclusion Criteria:\n\nAge younger than 18 yr or older than 70 yr\n\n* ASA class IV or V\n* Abnormalities of the heart, brain, liver, lung, kidney and coagulation function'}, 'identificationModule': {'nctId': 'NCT05739318', 'briefTitle': 'the Diameter of Double-lumen Tube Measured by Different Methods', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The First Hospital of Qinhuangdao'}, 'officialTitle': 'The Accuracy of the Diameter of Double-lumen Tube Measured by Different Methods as a Guide to the Size Selection of Double-lumen Tube', 'orgStudyIdInfo': {'id': '2022A123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The cuff of endotracheal and endobronchial is collapsed', 'description': 'The diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is collapsed', 'interventionNames': ['Device: The cuff of endotracheal and endobronchial is collapsed']}, {'type': 'EXPERIMENTAL', 'label': 'The cuff of endotracheal and endobronchial is inflated', 'description': 'The diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff is inflated', 'interventionNames': ['Device: The cuff of endotracheal and endobronchial is inflated']}], 'interventions': [{'name': 'The cuff of endotracheal and endobronchial is collapsed', 'type': 'DEVICE', 'description': "The diameter of double-lumen tube at the cuff of endotracheal and endobronchial when the cuff is collapsed as the diameter of double-lumen tube and select a double-lumen tube that matches the patient's trachea and bronchial innerdiameter based on this diameter", 'armGroupLabels': ['The cuff of endotracheal and endobronchial is collapsed']}, {'name': 'The cuff of endotracheal and endobronchial is inflated', 'type': 'DEVICE', 'description': "The diameter of double-lumen tube at the cuff of endotracheal and endobronchial when the cuff is inflated as the diameter of double-lumen tube and select a double-lumen tube that matches the patient's trachea and bronchial innerdiameter based on this diameter", 'armGroupLabels': ['The cuff of endotracheal and endobronchial is inflated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066000', 'city': 'Qinhuangdao', 'state': 'Hebei', 'country': 'China', 'facility': 'The first hospital of Qinhuangdao', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Qinhuangdao', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}