Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-28 @ 11:11 AM
Study NCT ID:
NCT04152733
Status:
UNKNOWN
Last Update Posted:
2020-04-22
First Post:
2019-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2019-11-03', 'studyFirstSubmitQcDate': '2019-11-03', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of desaturation', 'timeFrame': 'During deep sedation (during approximately 1 hour after propofol infusion)', 'description': 'Incidence of peripheral pulse oximeter value lower than 95%'}], 'secondaryOutcomes': [{'measure': 'Minimum pulse oximeter value', 'timeFrame': 'During deep sedation (during approximately 1 hour after propofol infusion)'}, {'measure': 'Incidence of peripheral pulse oximeter value lower than 90%', 'timeFrame': 'During deep sedation (during approximately 1 hour after propofol infusion)'}, {'measure': 'Incidence of changes in oxygen flow (control group) or FiO2 (HF group)', 'timeFrame': 'During deep sedation (during approximately 1 hour after propofol infusion)'}, {'measure': 'percutaneous CO2 value', 'timeFrame': 'During deep sedation (during approximately 1 hour after propofol infusion)'}, {'measure': 'Oxygen reserve index value', 'timeFrame': 'During deep sedation (during approximately 1 hour after propofol infusion)'}, {'measure': 'Incidence of manual ventilation', 'timeFrame': 'During deep sedation (during approximately 1 hour after propofol infusion)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Desaturation']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged \\<7 years\n* ASA class I, II\n\nExclusion Criteria:\n\n* Respiratory disease\n* Pneumothorax\n* Increased ICP\n* Nasal bleeding\n* Previous airway surgery\n* Trauma\n* Pulmonary hypertension'}, 'identificationModule': {'nctId': 'NCT04152733', 'briefTitle': 'Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population', 'orgStudyIdInfo': {'id': 'H1910-038-1068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Children in the control group receive oxygen via conventional nasal cannula during deep sedation. Oxygen flow is determined to set the fraction of inspired oxygen of 50%.'}, {'type': 'EXPERIMENTAL', 'label': 'High flow (HF) group', 'description': 'Children in the HF group receive oxygen via high flow nasal cannula during deep sedation. Fraction of inspired oxygen is set to 50%.', 'interventionNames': ['Device: High flow nasal cannula']}], 'interventions': [{'name': 'High flow nasal cannula', 'type': 'DEVICE', 'description': 'Oxygen is supplied via high flow nasal cannula. Heated air (2L/kg/min) is administered using Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand).', 'armGroupLabels': ['High flow (HF) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Tae Kim, Pf.', 'role': 'CONTACT', 'email': 'jintae73@gmail.com', 'phone': '+82-2-2072-3295'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jin-Tae Kim, MD, PhD', 'role': 'CONTACT', 'email': 'jintae73@gmail.com', 'phone': '82-2-2072-3661'}], 'overallOfficials': [{'name': 'Jin-Tae Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}