Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT04099069
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the fluctuation of heart rate', 'timeFrame': '24 hours', 'description': 'fluctuation of heart rate during the procedure'}, {'measure': 'the fluctuation of blood pressure', 'timeFrame': '24 hours', 'description': 'the fluctuation of blood pressure during the procedure'}, {'measure': 'the fluctuation of arterial partial pressure of carbon dioxide', 'timeFrame': '24 hours', 'description': 'the fluctuation of arterial partial pressure of carbon dioxide during the procedure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transbronchial Cryobiopsy', 'anesthesia', 'tracheal intubation', 'rigid bronchoscopy', 'safety', 'interstitial lung disease'], 'conditions': ['Transbronchial Cryobiopsy', 'Anesthesia', 'Tracheal Intubation', 'Rigid Bronchoscopy', 'Safety']}, 'descriptionModule': {'briefSummary': 'to evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy.', 'detailedDescription': 'To evaluate the difference between the tracheal intubation (TI) and rigid bronchoscopy (RB) under general anesthesia on patients with transbronchial cryobiopsy. Comparing the difference between two groups in the operating duration, extubation duration, total anesthesia time, heart rate, blood pressure and arterial blood gas analysis. This is a prospective, randomized, controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients are admitted in the institution as ILD, while undefined after thorough history collection, laboratory examination and radiological data.\n2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.\n3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed\n\nExclusion Criteria:\n\n1. The radiological data indicates non-ILD\n2. The clinical examinations mentioned above are not completed.\n3. The patient cannot endure or does not agree the procedure.'}, 'identificationModule': {'nctId': 'NCT04099069', 'briefTitle': 'The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy:A Prospective, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'TS20180110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'trachial intubation', 'description': 'patient was insert trachial intubation with normal frequency jet ventilation', 'interventionNames': ['Procedure: anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'rigid bronchoscopy', 'description': 'patient was insert trachial intubation with high frequency jet ventilation', 'interventionNames': ['Procedure: anesthesia']}], 'interventions': [{'name': 'anesthesia', 'type': 'PROCEDURE', 'otherNames': ['insert rigid bronchoscopy under general anesthesia'], 'description': 'patient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia', 'armGroupLabels': ['rigid bronchoscopy', 'trachial intubation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Xiaobo Chen, master', 'role': 'CONTACT', 'email': 'xiaobo-win@163.com', 'phone': '+8613751721744'}], 'facility': 'The first affilliated hospital of Guanghzhou Medical university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shiyue Li, master', 'role': 'CONTACT', 'email': 'lishiyue@188.com', 'phone': '+8613902233925'}, {'name': 'Xiaobo Chen, master', 'role': 'CONTACT', 'email': 'xiaobo-win@163.com', 'phone': '+8613751721744'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Institute of Respiratory Disease', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Respiratory department', 'investigatorFullName': 'ShiYue Li', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}