Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-03-01 @ 12:19 AM
Study NCT ID:
NCT02993666
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2016-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Upper and Lower Body Air Warming in Patients Undergoing Thoracic Surgery
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': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-09', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative incidence of hypothermia', 'timeFrame': 'through surgery completion, up to 4 hours'}]}, 'conditionsModule': {'conditions': ['Core Body Temperature']}, 'referencesModule': {'references': [{'pmid': '29452812', 'type': 'DERIVED', 'citation': 'Min SH, Yoon S, Yoon SH, Bahk JH, Seo JH. Randomised trial comparing forced-air warming to the upper or lower body to prevent hypothermia during thoracoscopic surgery in the lateral decubitus position. Br J Anaesth. 2018 Mar;120(3):555-562. doi: 10.1016/j.bja.2017.11.091. Epub 2017 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to evaluate the effectiveness of forced air warming using upper and lower body blankets by measuring core body temperature in patients undergoing video-assisted thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing video-assisted thoracic surgery over 2 hours\n* ASA I, II and III\n* age over 18 years\n\nExclusion Criteria:\n\n* refuse to enroll\n* patients with fever or hypothermia before surgery\n* patients who required changes of position during surgery'}, 'identificationModule': {'nctId': 'NCT02993666', 'briefTitle': 'Comparison of Upper and Lower Body Air Warming in Patients Undergoing Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'JHSeo_FAW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'upper body', 'description': 'warming with upper body blankets', 'interventionNames': ['Device: Bair Hugger']}, {'type': 'EXPERIMENTAL', 'label': 'lower body', 'description': 'warming with lower body blankets', 'interventionNames': ['Device: Bair Hugger']}], 'interventions': [{'name': 'Bair Hugger', 'type': 'DEVICE', 'description': 'forced air warming with Bair Hugger air warmer', 'armGroupLabels': ['lower body', 'upper body']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JH Seo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong-Hwa Seo', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}