Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT04868266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2021-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
End Tidal Carbon Dioxide in Minimal Sedation
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2021-04-25', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of oxygen desaturation', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'oxygen saturation lower than 95%'}], 'secondaryOutcomes': [{'measure': 'number of Staff intervetions', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'tactile stimulation, jaw thrust or head tilt, suction, oral or nasopharyngeal airway insertion, oxygen supply, laryngeal mask airway insertion, bag-valve mask ventilation, endotracheal intubation'}, {'measure': 'Severe oxygen desaturation', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'oxygen saturation lower than 85%, 90%'}, {'measure': 'Lowest oxygen saturation', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'value of oxygen saturation'}, {'measure': 'Episode of apnea', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'capnography flat line more than 5 seconds'}, {'measure': 'sedation level', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': '6-point pediatric sedation state scale'}, {'measure': 'inappropriate monitoring', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'the duration of inappropriate capnography monitoring'}, {'measure': 'Airway obstruction', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'stridor, retraction'}, {'measure': 'Integrated pulmonary index', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'calculated parameter'}, {'measure': 'success of procedure', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'success or fail of sedation or procedure'}, {'measure': 'Hemodynamic instability', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'heart rate and blood pressure change more than 20%'}, {'measure': 'Medication', 'timeFrame': 'from immediately after sedation to end of procedure, up to 2 hours', 'description': 'type and dosage of sedatives'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complication of Anesthesia']}, 'referencesModule': {'references': [{'pmid': '40810300', 'type': 'DERIVED', 'citation': 'Kim EH, Park JB, Ji SH, Jang YE, Lee JH, Kim HS, Kim JT. Using capnography in children to prevent oxygen desaturation during procedural sedation: A randomised trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):1034-1041. doi: 10.1097/EJA.0000000000002250. Epub 2025 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled study investigated the effect of end-tidal carbon dioxide monitoring in pediatric patients undergoing minimal sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients undergoing minimal sedation for procedure.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04868266', 'acronym': 'ETCO2', 'briefTitle': 'End Tidal Carbon Dioxide in Minimal Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of the Effect of Capnography for Preventing Hypoxia in Minimally Sedated Pediatric Patients', 'orgStudyIdInfo': {'id': 'D-2103-187-1208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'end tidal carbon dioxide monitoring', 'interventionNames': ['Other: end tidal carbon dioxide monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Oxygen saturation monitoring'}], 'interventions': [{'name': 'end tidal carbon dioxide monitoring', 'type': 'OTHER', 'description': 'We will monitor end tidal carbon dioxide with capnography during minimal sedation', 'armGroupLabels': ['end tidal carbon dioxide monitoring']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Jin-Tae Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}