Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 7:05 PM
Study NCT ID:
NCT04322994
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2020-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
THRIVE Use in Pediatric Populations- Multi Site
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D007040', 'term': 'Hypoventilation'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tjcaruso@stanford.edu', 'phone': '6507235728', 'title': 'Dr Thomas Caruso, MD, PhD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 days', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Participants undergo their scheduled procedure and recovery with the usual care.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 0, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High-flow Nasal Cannula', 'description': "Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion.", 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants undergo their scheduled procedure and recovery with the usual care.'}, {'id': 'OG001', 'title': 'High-flow Nasal Cannula', 'description': "Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion."}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '1 event', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '2+ events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'Analysis of between-group difference for participants with any desaturation event.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Chi-squared test of independence'}, {'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'Analysis of between-group difference for participants with 1 desaturation event versus 2 or more events.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Chi-squared test of independence'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', 'description': 'Oxygen desaturation index is defined as a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds; data were recorded every 2 seconds while the procedure was being performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Desaturations <90%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants undergo their scheduled procedure and recovery with the usual care.'}, {'id': 'OG001', 'title': 'High-flow Nasal Cannula', 'description': "Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion."}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '1 event', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '2+ events', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'Analysis of between-group difference for participants with at any qualifying desaturation event.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Chi-squared test of independence'}, {'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'Analysis of between-group difference for participants with 1 qualifying desaturation event versus 2 or more qualifying events.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Chi-squared test of independence'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', 'description': 'Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants undergo their scheduled procedure and recovery with the usual care.'}, {'id': 'OG001', 'title': 'High-flow Nasal Cannula', 'description': "Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion."}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '1 event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '2+ events', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Analysis of between-group difference for participants with any qualifying event.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'Analysis of between-group difference for participants with 1 qualifying event versus 2 or more events.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', 'description': 'Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed. Participants who experienced both a fall below 90% O2 and a 4% drop below baseline saturation are reported as having more than 1 event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol.'}, {'type': 'SECONDARY', 'title': 'Time-normalized Area Under Curve (AUC) of Desaturations <90%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants undergo their scheduled procedure and recovery with the usual care.'}, {'id': 'OG001', 'title': 'High-flow Nasal Cannula', 'description': "Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion."}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'Analysis of between-group difference for participants with at any qualifying desaturation event.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', 'description': 'Duration of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90% (in those participants who experienced desaturation less than 90%), normalized as area under the curve / total time.', 'unitOfMeasure': '% of blood oxygen saturation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced desaturation less than 90%'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Interruptions Due to Desaturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants undergo their scheduled procedure and recovery with the usual care.'}, {'id': 'OG001', 'title': 'High-flow Nasal Cannula', 'description': "Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion."}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '1 event', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '2+ events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'Analysis of between-group difference for participants with any surgical interruption.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Chi-squared test of independence'}, {'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'Analysis of between-group difference for participants with 1 surgical interruption versus 2 or more interruptions.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Chi-squared test of independence'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', '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 jaw thrust, bag mask ventilation, and/or endotracheal intubations.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol.'}, {'type': 'SECONDARY', 'title': 'Minimum Oxygen Saturation as a Measure of Desaturation Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Participants undergo their scheduled procedure and recovery with the usual care.'}, {'id': 'OG001', 'title': 'High-flow Nasal Cannula', 'description': "Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion."}], 'classes': [{'title': '0-50% O2 saturation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '50-70% O2 saturation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '70-90% O2 saturation', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '90-100% O2 saturation', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of surgery or procedure by second, which is generally less than 2 hours', 'description': 'Number of participants categorized by lowest oxygen saturation level during surgery (nadir). Lower saturation levels correspond to a lower level of oxygen in red blood cells.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gas Pain or Bloating', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Incidence of gas pain or bloating as measured by post-operative survey', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Nasal Irritation', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Incidence of nasal irritation as measured by post-operative survey', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sinus Pressure / Pain', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Incidence of sinus pressure and/or pain as measured by post-operative survey', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Headache', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Incidence of headache as measured by post-operative survey', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Other Adverse Events', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Other adverse events as measured by post-operative survey', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Participants undergo their scheduled procedure and recovery with the usual care.'}, {'id': 'FG001', 'title': 'High-flow Nasal Cannula', 'description': "Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'recruitmentDetails': "Participants were recruited from six pediatric sites (Lucile Packard Children's Hospital, Cincinnati Children's hospital, Lurie Children's Hospital, University of Virginia Children's Hospital, Massachusetts Eye and Ear Infirmary, and Boston Children's Hospital between October 2020 and January 2024. The first participant was enrolled on October 21, 2020 and the last participant was enrolled in January 19, 2024."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Participants undergo their scheduled procedure and recovery with the usual care.'}, {'id': 'BG001', 'title': 'High-flow Nasal Cannula', 'description': "Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Multirace', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who completed the protocol.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-08', 'size': 336598, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-11T20:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2020-03-21', 'resultsFirstSubmitDate': '2025-01-06', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-25', 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gas Pain or Bloating', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Incidence of gas pain or bloating as measured by post-operative survey'}, {'measure': 'Nasal Irritation', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Incidence of nasal irritation as measured by post-operative survey'}, {'measure': 'Sinus Pressure / Pain', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Incidence of sinus pressure and/or pain as measured by post-operative survey'}, {'measure': 'Headache', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Incidence of headache as measured by post-operative survey'}, {'measure': 'Other Adverse Events', 'timeFrame': 'Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively', 'description': 'Other adverse events as measured by post-operative survey'}], 'primaryOutcomes': [{'measure': 'Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', 'description': 'Oxygen desaturation index is defined as a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds; data were recorded every 2 seconds while the procedure was being performed.'}, {'measure': 'Number of Participants With Desaturations <90%', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', 'description': 'Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed.'}, {'measure': 'Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', 'description': 'Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed. Participants who experienced both a fall below 90% O2 and a 4% drop below baseline saturation are reported as having more than 1 event.'}], 'secondaryOutcomes': [{'measure': 'Time-normalized Area Under Curve (AUC) of Desaturations <90%', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', 'description': 'Duration of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90% (in those participants who experienced desaturation less than 90%), normalized as area under the curve / total time.'}, {'measure': 'Number of Participants With Surgical Interruptions Due to Desaturation', 'timeFrame': 'Duration of surgery or procedure, which is generally less than 2 hours', '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 jaw thrust, bag mask ventilation, and/or endotracheal intubations."}, {'measure': 'Minimum Oxygen Saturation as a Measure of Desaturation Severity', 'timeFrame': 'Duration of surgery or procedure by second, which is generally less than 2 hours', 'description': 'Number of participants categorized by lowest oxygen saturation level during surgery (nadir). Lower saturation levels correspond to a lower level of oxygen in red blood cells.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Oxygen Deficiency', 'Desaturation of Blood', 'Hypoventilation', 'Anesthesia; Adverse Effect']}, 'descriptionModule': {'briefSummary': 'THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) refers to the use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia. The use of high-flow nasal cannula oxygen supplementation during anesthesia for surgical procedures has been a recent development in the adult population, with limited data analyzing the pediatric population. This study will determine whether high flow nasal cannula oxygen supplementation during surgical or endoscopic procedures can prevent desaturation events in children under anesthesia and improve the outcomes of that surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients less than 18 years of age undergoing general anesthesia for procedures or surgeries\n\nExclusion Criteria:\n\n* Pregnancy\n* Absence of parent or legal guardian able to provide written consent for study participation\n* Anatomical or surgical contraindications (epistaxis, basilar skull fractures or abnormalities, nasal surgery or obstruction, nasal fractures, nasal vascular abnormalities), tracheostomy tube\n* Emergent surgery for which application of HFNC might delay surgery or might result in increased aspiration risk.'}, 'identificationModule': {'nctId': 'NCT04322994', 'briefTitle': 'THRIVE Use in Pediatric Populations- Multi Site', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Populations: A Randomized Prospective Multi-Site Trial', 'orgStudyIdInfo': {'id': '50881'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control subjects will undergo their scheduled procedure and recovery with the usual care. Following recovery from anesthesia, a brief questionnaire will be provided to applicable patients or their parents / guardians / representatives.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "Treatment subjects will undergo the scheduled procedure, with the difference being that a high-flow nasal cannula will be applied prior to the start of the procedure and removed following the procedure's conclusion. While applied, the cannula will deliver high- flow rate oxygen, air, or a mixture of variable oxygen concentration (21-100%) depending on the surgical conditions and requirements. The rate will be set at 1-4L/kg/min with a maximum of 70L/min. Participants in the treatment arm will then proceed to the recovery area as usual. Following recovery from anesthesia, a brief questionnaire will be provided to applicable patients or their parents / guardians / representatives.\n\nIntervention: Device: High-flow nasal cannula", 'interventionNames': ['Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange']}], 'interventions': [{'name': 'Transnasal Humidified Rapid-Insufflation Ventilatory Echange', 'type': 'DEVICE', 'description': 'The use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital Stanford", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachussetts Eye and Ear Harvard Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'The University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, {'name': "Boston Children's Hospital", 'class': 'OTHER'}, {'name': "UC Davis Children's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Thomas Caruso', 'investigatorAffiliation': 'Stanford University'}}}}