Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-02 @ 9:14 AM
Study NCT ID:
NCT04832256
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2021-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-01', 'studyFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2021-04-02', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effects of different fresh gas flows on carboxyhemoglobin levels', 'timeFrame': 'during surgery', 'description': 'To observe the effect of different fresh flows (1 L / min and 4 L / min) on the carboxyhemoglobin level by non-invasive and continuous measurement.'}], 'secondaryOutcomes': [{'measure': 'effects of smoking on carbon monoxide accumulation.', 'timeFrame': 'during surgery', 'description': 'to determine the contribution of smoking to intraoperative carbon monoxide accumulation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low flow anesthesia', 'Non-invasive carboxyhemoglobinemia monitoring', 'Smoking'], 'conditions': ['Fresh Flow', 'Carboxyhemoglobinemia']}, 'referencesModule': {'references': [{'pmid': '35964947', 'type': 'DERIVED', 'citation': 'Koksal BG, Kucukosman G, Ozcan P, Baytar C, Bollucuoglu K, Okyay RD, Ayoglu H. Effects of different fresh gas flows on carboxyhemoglobin levels: non-invasive carbon monoxide monitoring: A randomized clinical trial. Saudi Med J. 2022 Aug;43(8):891-898. doi: 10.15537/smj.2022.43.8.20220424.'}]}, 'descriptionModule': {'briefSummary': 'To observe the effect of different fresh flows (1 L / min and 4 L / min) on the carboxyhemoglobin level non-invasively and continuous measurement and to determine the contribution of smoking to the intraoperative carbon monoxide accumulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 64 patients in ASA I-II risk group, aged 18-65, undergoing 2-4 hours of elective surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* Undergo 2-4 hours of elective surgery\n\nExclusion Criteria:\n\n* Cardiovascular disease\n* diabetes mellitus\n* kidney, liver failure\n* chronic obstructive pulmonary disease\n* patients with opioid sensitivity\n* morbidly obese\n* personal or family history of malignant hyperthermia\n* history of prolonged recovery from anesthesia\n* alcohol addicted\n* pregnant and breastfeeding women patients allergic to study drugs'}, 'identificationModule': {'nctId': 'NCT04832256', 'briefTitle': 'Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels: Noninvasive Carbon Monoxide Monitoring', 'orgStudyIdInfo': {'id': '2015-67-07/07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High Flow anesthesia', 'description': 'administered 4 L/min fresh gas flow during general anesthesia', 'interventionNames': ['Device: Radical-7 Pulse CO-Oximeter']}, {'label': 'Low Flow Anesthesia', 'description': 'administered 1 L/min fresh gas flow during general anesthesia', 'interventionNames': ['Device: Radical-7 Pulse CO-Oximeter']}], 'interventions': [{'name': 'Radical-7 Pulse CO-Oximeter', 'type': 'DEVICE', 'description': 'COHb measurement monitoring from finger pulp with a non-invasive measurement device called Masimo Radical-7 Pulse co-oximeter (Masimo Corporation, Irvine, USA)', 'armGroupLabels': ['High Flow anesthesia', 'Low Flow Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67600', 'city': 'Zonguldak', 'state': 'Kozlu', 'country': 'Turkey (Türkiye)', 'facility': 'Zonguldak Bülent Ecevit University Medicine Faculty', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Doctor', 'investigatorFullName': 'Bengü Gülhan Aydin', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}