Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-05 @ 1:37 PM
Study NCT ID:
NCT02943928
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2016-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placement of the Double-Lumen Tube Without Fiberoptic Bronchoscope Assistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020704', 'term': 'Laryngoscopes'}], 'ancestors': [{'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2016-10-23', 'studyFirstSubmitQcDate': '2016-10-23', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation Time', 'timeFrame': 'Ten minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Therapeutic Procedural Complication']}, 'descriptionModule': {'briefSummary': 'laryngoscope combined with chest CT in double lumen endotracheal tube accurate positioning', 'detailedDescription': 'Comparing the traditional method of double lumen endotracheal tube intubation and laryngoscope combined with chest CT guide the precise localization of double lumen endotracheal tube'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI less than 35 kg/m2\n* ASA classifications of I-III, modified Mallampati classification 1 or 2 general anesthesia were included-\n\nExclusion Criteria:\n\n* Exclusion criteria included age younger than 18 yr\n* ASA class IV or V\n* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions-'}, 'identificationModule': {'nctId': 'NCT02943928', 'briefTitle': 'Placement of the Double-Lumen Tube Without Fiberoptic Bronchoscope Assistance', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The First Hospital of Qinhuangdao'}, 'officialTitle': 'Placement of the Double-Lumen Tube Without Fiberoptic Bronchoscope Assistance', 'orgStudyIdInfo': {'id': '2016A123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'laryngoscope and chest CT image', 'description': 'First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis.', 'interventionNames': ['Device: laryngoscope and chest CT image']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional method by experience', 'description': 'Operator inserted the double lumen tube by experience', 'interventionNames': ['Device: traditional method by experience']}], 'interventions': [{'name': 'laryngoscope and chest CT image', 'type': 'DEVICE', 'description': 'First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis', 'armGroupLabels': ['laryngoscope and chest CT image']}, {'name': 'traditional method by experience', 'type': 'DEVICE', 'description': 'Operator inserted the double lumen tube by experience', 'armGroupLabels': ['Traditional method by experience']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066000', 'city': 'Qinhuangdao', 'state': 'Hebei', 'country': 'China', 'facility': '中国', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}], 'overallOfficials': [{'name': 'Ximing Qi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Hospital of Qinhuangdao'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Qinhuangdao', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}