Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT01370993
Status:
UNKNOWN
Last Update Posted:
2011-06-10
First Post:
2011-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Prediction Model of Hypoxemia for Safe Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-09', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lowest oxygen saturation during bronchoscopy, development of hypoxemia(SpO2<90%) during bronchoscopy', 'timeFrame': 'during the fiberoptic bronchoscopy, estimated procedure time is about 15min'}], 'secondaryOutcomes': [{'measure': 'Need for oxygen flow increment', 'timeFrame': 'during the fiberoptic bronchoscopy, estimated procedure time is about 15min'}, {'measure': 'the proportion of subjects who is require of mandible lift', 'timeFrame': 'during the fiberoptic bronchoscopy, estimated procedure time is about 15min'}, {'measure': 'time delay for procedure due to hypoxemia', 'timeFrame': 'during the fiberoptic bronchoscopy, estimated procedure time is about 15min'}, {'measure': 'the proportion of subjects with snoring', 'timeFrame': 'during the fiberoptic bronchoscopy, estimated procedure time is about 15min', 'description': 'snoring'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypoxemia', 'Model', 'Bronchoscopes', 'Monitored anesthesia care'], 'conditions': ['Hypoxemia', 'Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop the hypoxemia prediction model during fiberoptic bronchoscopy under MAC(monitored anesthesia care) anesthesia.', 'detailedDescription': "Currently, diverse sedatives and analgesic methods are used during fiberoptic bronchoscopy for reducing patients' discomfort and facilities of procedures as British Thoracic Society recommendation. MAC anesthesia, one of the widely used sedative method during bronchoscopy, have many advantages, occurrence of respiratory depression, hypoxemia are not uncommon during the procedures. The investigators try to find out risk factors and develop the prediction model for hypoxemia during bronchoscopy under MAC anesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patienst who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 15 yrs\n* patients who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital\n\nExclusion Criteria:\n\n* Patients who will get Endobronchial ultrasound guided transbronchial needle aspiration\n* patients whose baseline oxygen saturation is below 90%\n* Intubated patients\n* Patients do not agree with the study enrollment'}, 'identificationModule': {'nctId': 'NCT01370993', 'briefTitle': 'The Prediction Model of Hypoxemia for Safe Bronchoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'The Prediction Model of Hypoxemia for Safe Bronchoscopy Under MAC Anesthesia', 'orgStudyIdInfo': {'id': 'SNUBH-FOB under MAC'}}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sei Won Lee, M.D.', 'role': 'CONTACT', 'email': 'seiwon@snubh.org', 'phone': '82-31-787-7053'}], 'facility': 'Sei Won Lee', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Sei Won Lee, M.D.', 'role': 'CONTACT', 'email': 'seiwon@snubh.org', 'phone': '82-31-787-7053'}], 'overallOfficials': [{'name': 'Sei Won Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sei Won Lee/Assistant professor', 'oldOrganization': 'Seoul National University Bundang Hospital'}}}}