Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
Study NCT ID:
NCT01493700
Status:
COMPLETED
Last Update Posted:
2013-06-27
First Post:
2011-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes of Body Temperature During Shoulder Arthroscopy
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-26', 'studyFirstSubmitDate': '2011-12-08', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of body temperature', 'timeFrame': 'every 15 minutes from base line', 'description': 'record the changes of esophageal and peripheral body temperature every 15 minutes from base line during shouler arthroscopy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['heated circuit', 'body temperature'], 'conditions': ['Hypothermia']}, 'referencesModule': {'references': [{'pmid': '21927679', 'type': 'RESULT', 'citation': 'Lee HK, Jang YH, Choi KW, Lee JH. The effect of electrically heated humidifier on the body temperature and blood loss in spinal surgery under general anesthesia. Korean J Anesthesiol. 2011 Aug;61(2):112-6. doi: 10.4097/kjae.2011.61.2.112. Epub 2011 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of electrically heated humidifier on the body temperature during shoulder arthroscopy.', 'detailedDescription': 'On the control group, use only routine anesthetic respiratory circuit for mechanical ventilation On the comparative group, use electrically heated humidifier for mechanical ventilation And compared the changes of body temperature durgin shoulder artheroscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American society of anesthesiologist physical status 1 or 2\n* 20-60 years old\n\nExclusion Criteria:\n\n* body mass index over 30 kg/m2\n* peripheral vascular disease\n* uncontrolled cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT01493700', 'briefTitle': 'Changes of Body Temperature During Shoulder Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Effect of Heated Humidifier on the Body Temperature During Shouler Arthroscopy', 'orgStudyIdInfo': {'id': 'GIRBA 2612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'control', 'description': 'use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy', 'interventionNames': ['Procedure: heated circuit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'electrically heated circuit', 'description': 'use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy', 'interventionNames': ['Procedure: control']}], 'interventions': [{'name': 'heated circuit', 'type': 'PROCEDURE', 'otherNames': ['heat circuit'], 'description': 'use electrically heated respiratory circuit (set at 37oC)during mechanical ventilation of anesthetic machine during shoulder arthroscopy', 'armGroupLabels': ['control']}, {'name': 'control', 'type': 'PROCEDURE', 'description': 'use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy', 'armGroupLabels': ['electrically heated circuit']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': 'Kyung Cheon Lee', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'Kyung Cheon Lee, MD.PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asistant professor', 'investigatorFullName': 'Youn Yi Jo', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}