Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-02-20 @ 12:42 PM
Study NCT ID:
NCT05214950
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2022-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen Reserve Index in Airway Surgery in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2022-01-18', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxemia', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'Oxygen desaturation \\<= 90%'}], 'secondaryOutcomes': [{'measure': 'Hypoxemia duration', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'Total length of time patient experienced hypoxemia during hypoxemic event (oxygen desaturation \\<= 90%)'}, {'measure': 'Incidence and duration of severe hypoxemia', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'incidence and duration of oxygen desaturation \\<=85%'}, {'measure': 'Rescue oxygenation', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'the number of the surgical procedure is interrupted and the anesthetist attempts to improve oxygenation of the child.'}, {'measure': 'Hemodynamic instability', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'occurrence of hypotension requiring treatment, bradycardia requiring treatment, cardiac arrest with or without return of spontaneous circulation at any time during procedure'}, {'measure': 'unexpected pediatric intensive care admission', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'requirements of unexpected pediatric intensive care admission'}, {'measure': 'unanticipated postoperative mechanical support', 'timeFrame': 'from induction of anesthesia to end of operation, about 3 hours', 'description': 'Requirement for unanticipated postoperative mechanical ventilation or any other form of non-invasive ventilation including high-flow nasal oxygen'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxemia During Surgery']}, 'descriptionModule': {'briefSummary': 'This study aimed to identify the effect of oxygen reserve index monitoring on the occurrence of oxygen desaturation (\\<90%) in pediatric patients undergoing airway surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients receiving airway surgery\n\nExclusion Criteria:\n\n* baseline oxygen saturation less than 95%\n* patients diagnosed as respiratory distress syndrome, bronchopulmonary dysplasia, pneumonia requiring oxygen supplements'}, 'identificationModule': {'nctId': 'NCT05214950', 'briefTitle': 'Oxygen Reserve Index in Airway Surgery in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of the Effect of Oxygen Reserve Index Monitoring for Preventing Hypoxia in Pediatric Airway Surgery', 'orgStudyIdInfo': {'id': '2112-055-1281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ORI monitoring', 'description': 'SpO2, ECG, NIBP, and oxygen reserve index monitoring', 'interventionNames': ['Device: ORI monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Standard monitoring', 'description': 'SpO2, ECG, NIBP monitoring'}], 'interventions': [{'name': 'ORI monitoring', 'type': 'DEVICE', 'description': 'Oxygen reserve index monitoring during the surgery', 'armGroupLabels': ['ORI monitoring']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Jin-Tae Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}