Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT06947902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that show an incidence of oxygen desaturation >5 %', 'timeFrame': 'from start of procedure to end of procedure (about 1 hour)'}], 'secondaryOutcomes': [{'measure': 'Apnea time measured in seconds or minutes', 'timeFrame': 'from start of procedure to end of procedure (about 1 hour)'}, {'measure': 'Number of Participants With Surgical Interruptions Due to Desaturation', 'timeFrame': 'from start of procedure to end of procedure (about 1 hour)', 'description': "Number of surgical interruptions due to desaturation defined by a pause in surgical procedures due to need to provide airway intervention to improve patient's oxygen saturation, normalized to case length. Airway interventions may include LMA, bag mask ventilation, and/or endotracheal intubations"}, {'measure': 'Oxygen nadir level', 'timeFrame': 'from start of procedure to end of procedure (about 1 hour)'}, {'measure': 'Transcutaneous CO2 measurements throughout procedure', 'timeFrame': 'from start of procedure to end of procedure (about 1 hour)'}, {'measure': 'Adverse events related to device itself (nasal pain, skin irritation)', 'timeFrame': 'from baseline to end of study (1 month after baseline)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['High Flow Nasal Cannula (HFNC)'], 'conditions': ['Airway Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate which flow rate (higher versus lower) is most effective at increasing apneic time and preventing greater than 5% drop in desaturation, as well as assessing transcutaneous carbon dioxide (CO2) levels during airway procedures in children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* undergoing laryngoscopy and bronchoscopy procedures at Children's Memorial Hermann Hospital (CMHH)\n* weight greater than or equal to 5 kilograms and using flow rates between 5 to 45 liters per minute (BTPS)\n\nExclusion Criteria:\n\n* Emergency type cases, tracheostomy patients, unrepaired cyanotic heart disease, nasal deformity/choanal atresia, or cautery/laser type procedures"}, 'identificationModule': {'nctId': 'NCT06947902', 'briefTitle': 'Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Optimizing High Flow Nasal Cannula Oxygenation in Pediatric Airway Procedures: a Randomized Study', 'orgStudyIdInfo': {'id': 'HSC-MS-25-0028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High flow', 'interventionNames': ['Device: High flow']}, {'type': 'EXPERIMENTAL', 'label': 'Low Flow', 'interventionNames': ['Device: Low Flow']}], 'interventions': [{'name': 'High flow', 'type': 'DEVICE', 'description': 'The High Flow Nasal Cannula (HFNC) device (Vapotherm) will be placed through the nostrils for oxygen (2L/kg per min with max of 45L)', 'armGroupLabels': ['High flow']}, {'name': 'Low Flow', 'type': 'DEVICE', 'description': 'The High Flow Nasal Cannula (HFNC) device (Vapotherm) will be placed through the nostrils for oxygen (0.5L/kg per min with max of 5L)', 'armGroupLabels': ['Low Flow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Zhen Huang, MD', 'role': 'CONTACT', 'email': 'Zhen.J.Huang@uth.tmc.edu', 'phone': '713-500-5419'}, {'name': 'Candace Hernandez', 'role': 'CONTACT', 'email': 'Candace.Hernandez@uth.tmc.edu', 'phone': '(713) 500-5410'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Zhen Huang, MD', 'role': 'CONTACT', 'email': 'Zhen.J.Huang@uth.tmc.edu', 'phone': '(713) 500-5419'}, {'name': 'Candace Hernandez', 'role': 'CONTACT', 'email': 'Candace.Hernandez@uth.tmc.edu', 'phone': '(713) 500-5410'}], 'overallOfficials': [{'name': 'Zhen Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zhen Huang', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}