Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-06 @ 7:06 PM
Study NCT ID:
NCT02625194
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2015-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Utility of Oxygen Insufflation During Flexible Fiberoptic Bronchoscope-guided Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2015-11-25', 'studyFirstSubmitQcDate': '2015-12-06', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Velocity of PaO2 decrease', 'timeFrame': 'from mask removal to 1st manual ventilation after intubation, up to 5 minute', 'description': 'After administration of anesthetic agents and manual ventilation of 5 minutes, arterial blood sampling is collected. Then bronchoscope-guided intubation performed and arterial blood sample is collected immediately after the intubation completed. Time for intubation (between 1st and 2nd blood sample) is recorded. The difference of PaO2(before \\& after intubation) is divided by the time taking for intubation.'}], 'secondaryOutcomes': [{'measure': 'success of intubation', 'timeFrame': '300 sec after the beginning of intubation', 'description': 'After 1st trial of intubation, the success of intubation is recorded. If it takes more than 300 sec, it will be considered failure.'}, {'measure': 'PaO2', 'timeFrame': '1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute', 'description': 'arterial blood samples are collected before and after intubation.'}, {'measure': 'PaCO2', 'timeFrame': '1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute', 'description': 'arterial blood samples are collected before and after intubation.'}, {'measure': 'pH', 'timeFrame': '1. 5 minutes after manual ventilation / 2.right before 1st manual ventilation after intubation, up to 5 minute', 'description': 'arterial blood samples are collected before and after intubation.'}, {'measure': 'visual field', 'timeFrame': 'throughout the intubation with bronchoscope, upto 5 minute', 'description': 'Visual field is evaluated by the blinded observer. It is evaluated as followed;excellent, good, poor, impossible'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lumbar Spinal Stenosis']}, 'referencesModule': {'references': [{'pmid': '33167909', 'type': 'DERIVED', 'citation': 'Roh GU, Kang JG, Han JY, Chang CH. Utility of oxygen insufflation through working channel during fiberoptic intubation in apneic patients: a prospective randomized controlled study. BMC Anesthesiol. 2020 Nov 10;20(1):282. doi: 10.1186/s12871-020-01201-9.'}]}, 'descriptionModule': {'briefSummary': 'This study investigate the utility of continuous oxygen insufflation during fiberoptic bronchoscope-guided intubation.\n\nOne group receives oxygen via suction channel of fiberoptic bronchoscope during intubation.\n\nThe other group does not receive oxygen during fiberoptic bronchoscope-guided intubation.\n\nThen, the velocity of deoxygenation difference of PaO2(baseline', 'detailedDescription': 'Fiberoptic bronchoscope-guided intubation is a gold standard for intubation of a patient with anticipating difficult airway. This technique takes several minutes without oxygen supply, which results in hypoxia when it prolonged. If continuous supply of oxygen during procedure improve the oxygenation, we can reduce the risk of hypoxemia and increase the safety margin during procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have surgery under general oral endotracheal anesthesia with invasive arterial blood pressure monitoring\n\nExclusion Criteria:\n\n* history of lung disease\n* abnormality in chest x-ray\n* anticipating difficult intubation\n* pregnant women\n* who is unable to understand and agree the consent form'}, 'identificationModule': {'nctId': 'NCT02625194', 'briefTitle': 'The Utility of Oxygen Insufflation During Flexible Fiberoptic Bronchoscope-guided Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Utility of Oxygen Insufflation During Flexible Fiberoptic Bronchoscope-guided Intubation', 'orgStudyIdInfo': {'id': '3-2015-0218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxygen', 'description': 'Oxygen is supplied through suction port in bronchoscope during bronchoscope-guided intubation.', 'interventionNames': ['Drug: Oxygen']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Bronchoscope-guided intubation is performed without oxygen supply.'}], 'interventions': [{'name': 'Oxygen', 'type': 'DRUG', 'description': 'Oxygen is supplied through suction port during bronchoscope-guided intubation.', 'armGroupLabels': ['Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong Soo Lee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yonsei University Gangnam Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}