Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:56 PM
Study NCT ID:
NCT00997295
Status:
COMPLETED
Last Update Posted:
2009-10-19
First Post:
2009-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heat and Moisture Exchanger and Low-flow Gas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-16', 'studyFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low flow gas', 'Heat and moisture exchanger', 'Humidity', 'Temperature', 'Core temperature', 'Women'], 'conditions': ['Gynecological Surgery', 'General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '21680862', 'type': 'DERIVED', 'citation': 'de Castro J Jr, Bolfi F, de Carvalho LR, Braz JR. The temperature and humidity in a low-flow anesthesia workstation with and without a heat and moisture exchanger. Anesth Analg. 2011 Sep;113(3):534-8. doi: 10.1213/ANE.0b013e31822402df. Epub 2011 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to measure the inspired gas temperature and humidity of the anesthetic circuit in the Dräger Primus machine and esophageal temperature with or without and heat and moisture exchanger (HME) and low-flow gas during anesthesia in patients submitted to gynecological surgeries.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Thirty adult patients scheduled to gynecologic surgeries were randomly assigned in two groups to received fresh gas flow of 1 l.min-1 with or without in circle anesthesia system. Relative humidity, absolute humidity, temperature of gases and esophageal temperature were measured at 15 min (T0)after respiratory circuit installation and then every 30 min up to 120 min afterwards.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* 18 to 69 years old\n* Gynecological\n\nExclusion Criteria:\n\n* Obesity\n* Fever\n* Endocrine disease'}, 'identificationModule': {'nctId': 'NCT00997295', 'briefTitle': 'Heat and Moisture Exchanger and Low-flow Gas', 'organization': {'class': 'OTHER', 'fullName': 'UPECLIN HC FM Botucatu Unesp'}, 'officialTitle': 'The Effects of a Heat and Moisture Exchanger on Temperature and Humidity in Low -Flow Anesthesia Workstation', 'orgStudyIdInfo': {'id': 'upeclin/HC/FMB-Unesp-29'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heat moisture exchanger (HME)', 'description': 'This group was submitted to general anesthesia with low flow gas and heat moisture exchanger'}, {'label': 'Low flow gas (LFG)', 'description': 'This group was submitted to general anesthesia with only low flow gas'}, {'label': 'Humidity of the respiration', 'description': 'Heat and moisture group:\n\nThe first group (G1)will be submitted to low flow gas anesthesia and heat and moisture exchanger (HME)\n\nControl group:\n\nThe second group(G2)Will be submitted to low flow gas anesthesia'}, {'label': 'HME and LFG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18618000', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'College of Medicine of Botucatu', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}], 'overallOfficials': [{'name': 'Jair Castro Jr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Botucatu Medical Faculty'}]}, '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 Committee of Botucatu Medical School', 'oldOrganization': 'Botucatu Medical School, UNESP'}}}}