Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT04852432
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2021-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 258}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2021-04-15', 'studyFirstSubmitQcDate': '2021-04-15', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Desaturation (≤95%)', 'timeFrame': 'through study completion, average 30 minutes', 'description': 'Occurrence of desaturation (pulse oximeter ≤95%)'}], 'secondaryOutcomes': [{'measure': 'Desaturation (≤90%)', 'timeFrame': 'through study completion, average 30 minutes', 'description': 'Occurrence of desaturation (pulse oximeter ≤90%)'}, {'measure': 'CO2 value', 'timeFrame': 'through study completion, average 30 minutes', 'description': 'percutaneous CO2 (maximum, minimum, mean values)'}, {'measure': 'Minimum saturation during sedation', 'timeFrame': 'through study completion, average 30 minutes'}, {'measure': 'Complications', 'timeFrame': 'through study completion, average 30 minutes', 'description': 'Any complications during sedation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Sedation']}, 'referencesModule': {'references': [{'pmid': '40215365', 'type': 'DERIVED', 'citation': 'Lee JH, Ko HJ, Park JB, Ji SH, Kim JT. Oxygen Supplementation in Pediatric Sedation: Prospective, Multicenter, Randomized Controlled Trial. Anesthesiology. 2025 Jul 1;143(1):132-141. doi: 10.1097/ALN.0000000000005500. Epub 2025 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children under the age of 18 who undergo moderate-deep sedation\n\nExclusion Criteria:\n\n* Respiratory failure patients\n* Increased intracranial pressure\n* Recent massive nasal bleeding\n* History of airway surgery\n* Complete nasal obstruction\n* Pulmonary hypertension\n* Skull base fracture'}, 'identificationModule': {'nctId': 'NCT04852432', 'briefTitle': 'Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients', 'orgStudyIdInfo': {'id': 'H2103-095-1205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Nasal prong is applied, but sedation is performed without oxygen administration.'}, {'type': 'EXPERIMENTAL', 'label': 'Low flow group', 'description': 'Oxygen administration by nasal cannula', 'interventionNames': ['Device: nasal prong']}, {'type': 'EXPERIMENTAL', 'label': 'High flow group', 'description': 'Oxygen is administered at a rate of 2L/kg/min using an Optiflow device', 'interventionNames': ['Device: high flow nasal cannula']}], 'interventions': [{'name': 'high flow nasal cannula', 'type': 'DEVICE', 'description': 'The heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%.', 'armGroupLabels': ['High flow group']}, {'name': 'nasal prong', 'type': 'DEVICE', 'description': 'Oxygen is administered via nasal prong', 'armGroupLabels': ['Low flow 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': '02-2072-3661', 'phoneExt': '82'}], 'overallOfficials': [{'name': 'Jin-Tae Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}