Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT03892408
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2019-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005547', 'term': 'Foreign Bodies'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014135', 'term': 'Tracheal Stenosis'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014133', 'term': 'Tracheal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'triple (Participant, Care Provider, investigator)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective Randomized, open label Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the lowest oxygen saturation', 'timeFrame': 'apnea period during the rigidbroscopic procedure/surgery', 'description': 'the lowest value of oxygen saturation measured percutaneously at extremity.'}], 'secondaryOutcomes': [{'measure': 'Hypoxia occurs the first time', 'timeFrame': 'intraoperative (The time taken to reach the point at which peripheral oxygen saturation fell below 90 for the first time immediately after the onset of apnea)'}, {'measure': 'End-tidal carbon dioxide partial pressure', 'timeFrame': 'Intraoperative (end-tidal CO2 partial pressure after 3 consecutive breaths after intubation or insertion of laryngeal mask following end of apnea)'}, {'measure': 'Arterial oxygen / carbon dioxide partial pressure', 'timeFrame': 'shortly before start of apnea (within 30 seconds)'}, {'measure': 'Arterial oxygen / carbon dioxide partial pressure', 'timeFrame': 'shortly after end of apnea (within 30 seconds)'}, {'measure': 'hypoxemia related surgical interruptions', 'timeFrame': '4) hypoxemia related surgical interruptions during apneic period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Foreign Bodies', 'Tumor', 'Stenosis Trachea', 'Bronchus Tumour']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of high-flow nasal cannula oxygen administration on apnea in patients undergoing general anesthesia with rigid bronchoscopy compared with standard anesthesia methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients undergoing general anesthesia with stent placement or bougination, biopsy or removal of a foreign body or a mass through a rigid bronchoscope\n* 2\\. Patients aged 19 or older who meet American Society of Anesthesiologists (ASA) physical class 2-4\n\nExclusion Criteria:\n\n* 1\\. Patients with dementia or cognitive impairment\n* 2\\. pregnant women\n* 3\\. Patients undergoing extracorporeal membrane oxygenation (ECMO)\n* 4\\. Patients with active nasal bleeding), severe nasal obstruction, recent nasal trauma of surgery\n* 5\\. Patients with current maxillofacial trauma or basal skull fracture\n* 6\\. Patients who had previously undergone rigid bronchoscopy / surgery\n* 7\\. If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)'}, 'identificationModule': {'nctId': 'NCT03892408', 'briefTitle': 'High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'High-flow Nasal Oxygen During Rigid Bronchoscopy Under General Anesthesia: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1-2019-0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optiflow', 'description': '100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand)', 'interventionNames': ['Device: Optiflow ™']}, {'type': 'NO_INTERVENTION', 'label': 'Standard', 'description': 'standard anesthesia'}], 'interventions': [{'name': 'Optiflow ™', 'type': 'DEVICE', 'description': 'supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period.', 'armGroupLabels': ['Optiflow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}