Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:50 AM
Study NCT ID:
NCT05349734
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2022-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Upper Body and Full Underbody Forced Air Blanket in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2022-04-09', 'studyFirstSubmitQcDate': '2022-04-26', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hypothermia', 'timeFrame': 'intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)', 'description': 'time weighted average out of normothernia (body temperature over 37.5℃ and under 36.5℃) in intraoperative period'}], 'secondaryOutcomes': [{'measure': 'hyperthermia', 'timeFrame': 'intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)', 'description': 'body temperature recorded over 37.5℃'}, {'measure': 'thermal comfort scale', 'timeFrame': '15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit', 'description': 'asking subjects about the thermal sensation on a seven-point scale from cold(-3) to hot (+3)'}, {'measure': 'patient satifisfaction at post-anesthesia care unit', 'timeFrame': '15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit', 'description': 'visual analog scale score for measuring the patient satisfaction after the surgery (0\\~10)'}, {'measure': 'shivering score at post-anesthesia care unit', 'timeFrame': '15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit', 'description': '4 grades of shivering score measured at post-anesthesia care unit'}, {'measure': 'clinical outcomes after the surgery', 'timeFrame': '5 days after the surgery', 'description': 'postoperative complications during hospitalization'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypothermia; Anesthesia']}, 'referencesModule': {'references': [{'pmid': '40399788', 'type': 'DERIVED', 'citation': 'Park JB, Kim TW, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. Comparison between upper body and full underbody forced-air warming blanket in pediatric patients undergoing cardiovascular interventions under general anesthesia: a randomized controlled trial. BMC Anesthesiol. 2025 May 21;25(1):254. doi: 10.1186/s12871-025-03100-3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the underbody blanket and overbody blanket for forced air warming to maintain normothermia in pediatric patients undergoing cardiovascular interventions under general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients under 15 years of age who are scheduled for cardiovascular interventions in angioroom\n\nExclusion Criteria:\n\n* anticipated operating time \\< 1 hour\n* body surface area that exposured by drape \\< 30% of total body surface area\n* BMI \\> 30\n* corrected age \\< 40 weeks\n* preoperative body temperature is higher than 37℃ or less than 35.5℃\n* patients with skin disease\n* history of malignant hyperthermia\n* patients who cannot use esophageal stethoscope'}, 'identificationModule': {'nctId': 'NCT05349734', 'briefTitle': 'Comparison of Upper Body and Full Underbody Forced Air Blanket in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Upper Body and Full Underbody Forced Air Blanket for Maintaining Normothermia in Pediatric Patients Undergoing Cardiovascular Interventions Under General Anesthesia: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2005-016-1121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'upper body', 'interventionNames': ['Other: upper body blanket']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'full underbody', 'interventionNames': ['Other: full underbody blanket']}], 'interventions': [{'name': 'upper body blanket', 'type': 'OTHER', 'description': 'applying upper body blanket with forced-air blower set to 43℃', 'armGroupLabels': ['upper body']}, {'name': 'full underbody blanket', 'type': 'OTHER', 'description': 'applying full underbody blanket with forced-air blower set to 43℃', 'armGroupLabels': ['full underbody']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hee-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}