Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02013869
Status:
TERMINATED
Last Update Posted:
2024-03-19
First Post:
2013-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Flow Anaesthesia, is There a Difference Between 2 Modern Anaesthetic Machines Using Different Gas Reservoir
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-11-17', 'size': 353468, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-14T17:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We studied the time to reach a MAC value for two fifferent anaesthetic machines, Flow-i versus Aisys looking at the time to reach 1 MAC desflurane'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Two of the sites withdraw, did not have capacity to recruit patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-16', 'studyFirstSubmitDate': '2013-11-29', 'studyFirstSubmitQcDate': '2013-12-11', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adequate anaesthesia', 'timeFrame': '5 hours', 'description': 'Patients will be asked after end of anaesthesia if they have had any recall of intraoperative events'}], 'primaryOutcomes': [{'measure': 'Time to reach 1.5 MAC (minimal alveolar concentration) Et', 'timeFrame': '1 hour', 'description': 'The time needed, seconds, to increase the end tidal desflurane concentration during wash-in from a 1 MAC to a 1.5 MAC with a constant fresh gas flow of 1 L/min and the vaporiser set a 3 MAC ( minimal alveolar concentration) (18%) will be compared between the two study groups'}], 'secondaryOutcomes': [{'measure': 'amount of inhaled agent consumed ml/min', 'timeFrame': '5 hours', 'description': 'The vaporiser will be weighed before and after each case and the amount of vapor, desflurane, consumed during the anaesthesia will be calculated Gr/min.'}, {'measure': 'Postoperative Quality of Recovery', 'timeFrame': '72 hours', 'description': 'Quality of recovery will be followed during the first 72 hours after anaesthesia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fresh gas flow', 'quality of anaesthesia', 'minimal alveolar concentration'], 'conditions': ['General Anaesthesia']}, 'descriptionModule': {'briefSummary': 'To study the Flow-I breathing circle during low flow general anaesthesia, whether this non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar concentration) and lower consumption of inhaled agent', 'detailedDescription': 'Assessing whether there are clinical differences in anaesthetic performance between standard anaesthesia workstation including a below and the new Flow-I device without a below'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nASA 1-2 patient 18 - 65 years scheduled for elective surgery\n\nExclusion Criteria:\n\nASA \\> 2 heart failure COPD'}, 'identificationModule': {'nctId': 'NCT02013869', 'acronym': 'LF', 'briefTitle': 'Low Flow Anaesthesia, is There a Difference Between 2 Modern Anaesthetic Machines Using Different Gas Reservoir', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Low Flow Anaesthesia; Cost-effectiveness of the Flow-I Anaesthesia Machine, a Comparison to Established Anaesthesia Delivery Unit', 'orgStudyIdInfo': {'id': '201301'}, 'secondaryIdInfos': [{'id': 'JJ201301', 'type': 'OTHER_GRANT', 'domain': 'M201301'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flow-I', 'description': 'Wash in of desflurane (SupraneR) in an anaesthesia machine without below, a new technique that do not have abag/reservoir that is compressed but pushes the gas into the patient. This technique uses far less of fresh gas volume. Thus lower anaesthetic gas will be consumed per hour.\n\nThe primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used.', 'interventionNames': ['Device: Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Asys', 'description': 'Wash in of desflurane (Suprane) in conventional anaesthesia machine Asys, with the anaesthesia machine Asys that has a bag/reservoir that is compressed for insufflation of gas into the patient, thus it is expected that more gas will be consumed per hour.\n\nThe primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used.', 'interventionNames': ['Device: Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated']}], 'interventions': [{'name': 'Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas', 'type': 'DEVICE', 'description': 'Desflurane Dialed setting 18 % on the machine gas vaporized', 'armGroupLabels': ['Flow-I']}, {'name': 'Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated', 'type': 'DEVICE', 'description': 'Desflurane dialed 18% on the machine gas vaporized', 'armGroupLabels': ['Asys']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyds Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Jan g Jakobsson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jan Jakobsson', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Irvine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Adj Professor', 'investigatorFullName': 'Jan Jakobsson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}