Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-27 @ 4:00 PM
Study NCT ID:
NCT05762692
Status:
UNKNOWN
Last Update Posted:
2023-08-04
First Post:
2023-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-flow Nasal Oxygenation During Deep Sedation in Pediatric Dental Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxemia', 'timeFrame': 'Intra-operative', 'description': 'The occurrence of decreased oxygen saturation up to 90%.'}], 'secondaryOutcomes': [{'measure': 'Severe Hypoxemia', 'timeFrame': 'Intra-operative', 'description': 'The occurrence of decreased oxygen saturation up to 85%'}, {'measure': 'Desaturation', 'timeFrame': 'Intra-operative', 'description': 'The occurrence of decreased oxygen saturation up to 94%.'}, {'measure': 'Intra-operative airway assistance', 'timeFrame': 'Intra-operative', 'description': 'The need of intra-operative airway assistance maneuvers including jaw lifting, suction, mask ventilation and intubation.'}, {'measure': 'Operation interruption', 'timeFrame': 'Intra-operative', 'description': 'The occurrence of intra-operative surgical operation interruption due to decreased oxygen saturation, secretion, airway suction, severe body movement, etc., except for surgical reasons.'}, {'measure': 'Intra-operative end-tidal carbon dioxide level', 'timeFrame': 'Intra-operative', 'description': 'The highest intra-operative end-tidal carbon dioxide level.'}, {'measure': 'Intra-operative transcutaneous carbon dioxide level', 'timeFrame': 'Intra-operative', 'description': 'The highest intra-operative transcutaneous carbon dioxide level.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-flow nasal oxygenation', 'dental treatment', 'children'], 'conditions': ['Deep Sedation', 'Dental Treatment', 'Pediatric Patients']}, 'descriptionModule': {'briefSummary': 'It is important to choose an appropriate oxygenation technique during intravenous deep sedation in pediatric dental treatment. The study is to evaluate the efficacy and safety of high-flow nasal oxygenation in intravenous deep sedation in pediatric dental patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. children in need of deep sedation for dental treatment aged 3-7 years.\n2. anticipated operation time over 60 mins.\n\nExclusion Criteria:\n\n1. Conditions which the attending considers to be unfit for elective surgery or tubeless anesthesia.\n2. Any contraindications of high flow nasal oxygenation.\n3. Any contraindications or allergic history of propofol.'}, 'identificationModule': {'nctId': 'NCT05762692', 'briefTitle': 'High-flow Nasal Oxygenation During Deep Sedation in Pediatric Dental Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Clinical Feasibility and Efficacy of High-flow Nasal Oxygenation During Intravenous Deep Sedation in Pediatric Dental Patients', 'orgStudyIdInfo': {'id': 'PKUSSIRB-202283174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HFNO Group', 'description': 'Intra-operative oxygenation will be administered by the high-flow nasal oxygenation device. The flow rate is 2L/kg.(upper limit 30L/min)', 'interventionNames': ['Device: High-flow nasal oxygenation device']}], 'interventions': [{'name': 'High-flow nasal oxygenation device', 'type': 'DEVICE', 'description': 'The patients included will be oxygenated by HFNO device during the operation', 'armGroupLabels': ['HFNO Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xudong Yang', 'role': 'CONTACT'}], 'facility': 'Peking University of Stomatology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xudong Yang, MD', 'role': 'CONTACT', 'email': 'kqyangxudong@163.com', 'phone': '18810086060'}, {'name': 'Tong Cheng, MD', 'role': 'CONTACT', 'email': 'chengtong@foxmail.com', 'phone': '15811229030'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Department of Anesthesiology', 'investigatorFullName': 'Yang Xudong', 'investigatorAffiliation': 'Peking University'}}}}