Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-01-24 @ 4:05 PM
Study NCT ID:
NCT04057612
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2019-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Core Temperature and Skin Temperature in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001832', 'term': 'Body Temperature Changes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Esophageal core temperature measured by stethoscope, ℃', 'timeFrame': '3 hours (during general anesthesia)', 'description': 'Temperature measured by esophageal stethoscope, ℃'}, {'measure': 'Carotid skin temperature by 3M™ Bair Hugger™, ℃', 'timeFrame': '3 hours (during general anesthesia)', 'description': 'Temperature measured by 3M™ Bair Hugger™ near to carotid artery, ℃'}], 'secondaryOutcomes': [{'measure': 'Room temperature, ℃', 'timeFrame': '3 hours (during general anesthesia)', 'description': 'Operating room temperature, ℃'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'temperature', 'general anesthesia'], 'conditions': ['Temperature Change, Body', 'Anesthesia', 'Children, Only']}, 'descriptionModule': {'briefSummary': 'During general anesthesia, temperature monitoring is critical especially in pediatrics. Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measure by esophageal prove in several studies. Conventional skin temperature over carotid artery is also correlated with core temperature in several studies. The purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.', 'detailedDescription': 'Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery, besides, pediatric patients are more vulnerable in temperature control. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measured by esophageal prove in several studies. Its mechanism is making zero heat flux on skin applied. But it also cannot apply in head or facial surgery. Other studies showed conventional skin temperature over carotid artery is also correlated with core temperature. The investigators hypothesized using 3M™ Bair Hugger™ on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients aged 1 to 5 years old who scheduled surgery under general anesthesia. Who need esophageal temperature monitoring for routine monitoring.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* scheduled operation under general anesthesia\n* Who need esophageal temperature monitoring\n* American society of anesthesiology physical status 1 or 2\n\nExclusion Criteria:\n\n* Body mass index \\> 35 kg/m2\n* Who cannot be inserted esophageal temperature prove\n* Patients with fever \\> 38'C\n* History of malignant hyperthermia"}, 'identificationModule': {'nctId': 'NCT04057612', 'acronym': 'temperature', 'briefTitle': 'Correlation Between Core Temperature and Skin Temperature in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Correlation Between Core Temperature and Skin Temperature Near Carotid Artery Measured by 3M™ Bair Hugger™ in Pediatrics', 'orgStudyIdInfo': {'id': 'AJIRB-MED-OBS-19-277'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric participants', 'description': "Participants' temperature measured at 2 places at the same time\n\n* Esophagus\n* Skin near to carotid artery", 'interventionNames': ['Other: Esophagus temperature monitoring', 'Other: Carotid artery temperature monitoring']}], 'interventions': [{'name': 'Esophagus temperature monitoring', 'type': 'OTHER', 'otherNames': ['core temperature'], 'description': 'Measuring core temperature by esophageal stethoscope', 'armGroupLabels': ['Pediatric participants']}, {'name': 'Carotid artery temperature monitoring', 'type': 'OTHER', 'otherNames': ['3M™ Bair Hugger™ temperature monitoring'], 'description': 'Measuring temperature on skin near to carotid artery using 3M™ Bair Hugger™ temperature monitoring system', 'armGroupLabels': ['Pediatric participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou university school of medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'In Kyong Yi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'In-kyong Yi', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}