Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-29 @ 5:13 PM
Study NCT ID:
NCT01026766
Status:
COMPLETED
Last Update Posted:
2009-12-04
First Post:
2009-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Heat and Moisture Exchanger in Combination With Air Forced Warming Blankets or Warming Intravenous Solutions on Intraoperative Hypothermia Prevention in Obese and Non Obese Patients During Intravenous Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-03', 'studyFirstSubmitDate': '2009-12-03', 'studyFirstSubmitQcDate': '2009-12-03', 'lastUpdatePostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypothermia', 'Obesity', 'Heat and moisture exchanger', 'Warming blanket', 'Warming fluids', 'Gynecological surgery', 'Intravenous anesthesia', 'Obese patients', 'Non obese patients'], 'conditions': ['Hypothermia']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to evaluate if the combination of heat and moisture exchanger with air forced warming blankets or warming intravenous fluids prevents intraoperative hypothermia in obese and non obese women under target controlled infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Forty female obese and non obese patients scheduled to gynecologic surgeries were warmed with warming blankets and warming intravenous fluids in association with heat and moisture exchanger.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women\n* 18-65 years old\n* gynecologic\n* obesity\n\nExclusion Criteria:\n\n* fever\n* endocrine disease\n* hypertension\n* vasoactive drugs'}, 'identificationModule': {'nctId': 'NCT01026766', 'briefTitle': 'Effects of Heat and Moisture Exchanger in Combination With Air Forced Warming Blankets or Warming Intravenous Solutions on Intraoperative Hypothermia Prevention in Obese and Non Obese Patients During Intravenous Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'UPECLIN HC FM Botucatu Unesp'}, 'orgStudyIdInfo': {'id': 'upeclin/HC/FMB-Unesp-32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non obese/ Warming blankets'}, {'label': 'Non obese/ Warming intravenous fluids'}, {'label': 'Obese/ Warming intravenous fluids'}, {'label': 'Obese/ Warming blankets'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'College of Medicine of Botucatu', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}], 'overallOfficials': [{'name': 'Luciano A Fernandes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Botucatu Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UPECLIN HC FM Botucatu Unesp', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Clinical Research Ethic Comittee of Botucatu', 'oldOrganization': 'Botucatu Medical School, UNESP'}}}}