Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT06389669
Status:
COMPLETED
Last Update Posted:
2024-10-03
First Post:
2024-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is Low Flow Anaesthesia Feasible?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 785}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Low Flow Anaesthesia', 'timeFrame': 'The measurement will start 10 minutes after the surgical incision and end 20 minutes later', 'description': 'To determine the lowest amount of fresh gas flow, most suitable for the patient and, which can provide FiO2=40% level'}], 'secondaryOutcomes': [{'measure': 'Factors affecting oxygen consumption', 'timeFrame': 'The measurement will start 10 minutes after the surgical incision and end 20 minutes later', 'description': "To find out which of the patient's physical characteristics that affect oxygen consumption may be determinant."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low Flow Anaesthesia', 'Closed-Circuit Anesthesia'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Although the risk of hypoxia is almost prevented with advanced anaesthesia machines, the use of LFA has not reached the desired levels. However, in recent years, as adverse developments related to climate change have started to affect us all, LFA has started to be on the agenda of anaesthetists again. In this study, our aim is to examine the feasibility of its clinical use in order to popularise the use of LFA.', 'detailedDescription': 'ASA 1-2 patients who will undergo elective surgery under general anaesthesia in 38 operating rooms of Inonu University Faculty of Medicine will be prospectively recruited for 3 months (May-June-July). Emergency cases, patients under the age of 18 and over 65, laparoscopic surgeries, heart-lung surgeries that may impair oxygenation will not be included in the study.\n\nInhaler anaesthesia will be administered after anaesthesia induction and tracheal intubation. Fresh gas flow (FGF) will be determined as 1 l/min, MAC=1, FiO2=40% with target controlled automatic gas control mode (AGC). FGF will be decreased to 0.5 l/min 10 minutes after surgical incision, if successful, it will be decreased to 0.3 l/min 10 minutes later and it will be checked whether it is successful. The study will be terminated and FGF will be increased to 1 l/min again.\n\nDemographic data of the patients and FGF levels that can provide FiO2=40% will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ASA 1-2 patients who will undergo elective surgery under general anaesthesia in 38 operating rooms of Inonu University Faculty of Medicine will be prospectively recruited for 3 months (May-June-July). Emergency cases, patients under the age of 18 and over 65, laparoscopic surgeries, heart-lung surgeries that may impair oxygenation will not be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing surgery under general anaesthesia\n\nExclusion Criteria:\n\n* Emergency operations\n* Previously diagnosed heart, lung, liver and kidney disease\n* Surgeries that may impair oxygenation (laparoscopic, Heart, Lung surgeries)'}, 'identificationModule': {'nctId': 'NCT06389669', 'briefTitle': 'Is Low Flow Anaesthesia Feasible?', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Low Flow Anaesthesia is Good But Feasible?', 'orgStudyIdInfo': {'id': 'Inonu LTI'}}, 'contactsLocationsModule': {'locations': [{'zip': '44280', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu Univercity', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Yusuf Z Colak, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inonu University Anaesthesiology and Reanimation Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD', 'investigatorFullName': 'Yusuf Ziya ÇOLAK', 'investigatorAffiliation': 'Inonu University'}}}}