Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-02 @ 4:53 AM
Study NCT ID:
NCT06055335
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2023-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Lung Dynamics and Respiratory Functions in Minimal Flow Anesthesia: A Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic Compliance assessment', 'timeFrame': '5th minutes after endotracheal intubation', 'description': 'Dynamic Compliance will be assessed 5th minutes after endotracheal intubation'}, {'measure': 'Dynamic Compliance assessment', 'timeFrame': '5th minutes after surgical incision', 'description': 'Dynamic Compliance will be assessed 5th minutes after the surgical incision'}, {'measure': 'Dynamic Compliance assessment', 'timeFrame': '10th minutes after surgical incision', 'description': 'Dynamic Compliance will be assessed 10th minutes after the surgical incision'}, {'measure': 'Dynamic Compliance assessment', 'timeFrame': '30th minutes after surgical incision', 'description': 'Dynamic Compliance will be assessed 30th minutes after the surgical incision'}, {'measure': 'Dynamic Compliance assessment', 'timeFrame': '60th minutes after surgical incision', 'description': 'Dynamic Compliance will be assessed 60th minutes after the surgical incision'}, {'measure': 'Dynamic Compliance assessment', 'timeFrame': 'immediately after the end of the surgical suturing', 'description': 'Dynamic Compliance will be assessed immediately after the end of the surgical suturing'}, {'measure': 'Peak inspiratory pressure assessment', 'timeFrame': '5th minutes after endotracheal intubation', 'description': 'Peak inspiratory pressure will be assessed 5th minutes after endotracheal intubation'}, {'measure': 'Peak inspiratory pressure assessment', 'timeFrame': '5th minutes after the surgical incision', 'description': 'Peak inspiratory pressure will be assessed 5th minutes after the surgical incision'}, {'measure': 'Peak inspiratory pressure assessment', 'timeFrame': '10th minutes after the surgical incision', 'description': 'Peak inspiratory pressure will be assessed 10th minutes after the surgical incision'}, {'measure': 'Peak inspiratory pressure assessment', 'timeFrame': '30th minutes after the surgical incision', 'description': 'Peak inspiratory pressure will be assessed 30th minutes after the surgical incision'}, {'measure': 'Peak inspiratory pressure assessment', 'timeFrame': '60th minutes after the surgical incision', 'description': 'Peak inspiratory pressure will be assessed 60th minutes after the surgical incision'}, {'measure': 'Peak inspiratory pressure assessment', 'timeFrame': 'immediately after the end of the surgical suturing', 'description': 'Peak inspiratory pressure will be assessed immediately after the end of the surgical suturing'}], 'secondaryOutcomes': [{'measure': 'FEV1 measures assessment', 'timeFrame': '24 hours before the operation', 'description': 'FEV1 measures assessment will be assessed 24 hours before the operation'}, {'measure': 'FEV1 measures assessment', 'timeFrame': '2nd hour after the operation', 'description': 'FEV1 measures assessment will be assessed 2nd hours after the operation'}, {'measure': 'FEV1 measures assessmentt', 'timeFrame': '8th hour after the operation', 'description': 'FEV1 measures assessment will be assessed 8th hours after the operation'}, {'measure': 'FEV1 measures assessment', 'timeFrame': '24th hour after the operation', 'description': 'FEV1 measures assessment will be assessed 24th hours after the operation'}, {'measure': 'FVC measures assessment', 'timeFrame': '24 hours before the operation', 'description': 'FVC measures assessment will be assessed 24 hours before the operation'}, {'measure': 'FVC measures assessment', 'timeFrame': '2nd hour after the operation', 'description': 'FVC measures assessment will be assessed 2nd hour after the operation'}, {'measure': 'FVC measures assessment', 'timeFrame': '8th hour after the operation', 'description': 'FVC measures assessment will be assessed 8th hour after the operation'}, {'measure': 'FVC measures assessment', 'timeFrame': '24th hour after the operation', 'description': 'FVC measures assessment will be assessed 24th hours after the operation'}, {'measure': 'FEV1/FVC measures assessment', 'timeFrame': '24 hours before the operation', 'description': 'FEV1/FVC measures assessment will be assessed 24 hours before the operation'}, {'measure': 'FEV1/FVC measures assessment', 'timeFrame': '2nd hour after the operation', 'description': 'FEV1/FVC measures assessment will be assessed 2nd hour after the operation'}, {'measure': 'FEV1/FVC measures assessment', 'timeFrame': '8th hour after the operation', 'description': 'FEV1/FVC measures assessment will be assessed 8th hour after the operation'}, {'measure': 'FEV1/FVC measures assessment', 'timeFrame': '24th hour after the operation', 'description': 'FEV1/FVC measures assessment will be assessed 24th hour after the operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medium Flow Anesthesia', 'Minimal Flow Anesthesia', 'Pulmonary Function Test', 'Compliance, Patient', 'Peak Inspiratuar Pressure']}, 'referencesModule': {'references': [{'pmid': '40826933', 'type': 'DERIVED', 'citation': 'Celik EC, Yayik AM, Aydin ME, Koksal ENM, Disci E, Kerget B, Doymus O, Ahiskalioglu EO, Ahiskalioglu A. Evaluation of lung dynamics and respiratory functions in patients undergoing minimal flow anesthesia: a prospective, randomized controlled trial. Med Gas Res. 2026 Jun 1;16(2):110-115. doi: 10.4103/mgr.MEDGASRES-D-25-00037. Epub 2025 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'The patients were randomized into two groups medium flow anesthesia (MeFA) and minimal flow anesthesia (MiFA). While MeFA received medium flow anesthesia with 2 lt/min, MiFA received minimal flow anesthesia with 0.5 lt/min fresh gas flow. In both groups dynamic compliance values, peak inspiratory pressure (PIP) values, total inhalation anesthetic drug consumption, total remifentanil drug consumption, duration of anesthesia, and duration of surgery were recorded. The FVC, FEV1, and FEV1/FVC values of the patients in both groups were evaluated and noted 24 hours before the operation, after the operation 2nd, 8th, and 24th hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* 18-65 years of age, who will undergo elective laparoscopic cholecystectomy surgery\n\nExclusion Criteria:\n\n* ASA III-IV\n* Smokers\n* Body mass index (BMI) \\> 40 kg / m2,\n* Patients with cardiovascular system disease\n* Chronic respiratory diseases,\n* Patients whose pulmonary function tests cannot be applied and who have problems with pulmonary function tests during the examination of the chest disease consultant'}, 'identificationModule': {'nctId': 'NCT06055335', 'briefTitle': 'Assessing Lung Dynamics and Respiratory Functions in Minimal Flow Anesthesia: A Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'EVALUATION OF LUNG DYNAMICS AND RESPIRATORY FUNCTIONS IN PATIENTS APPLIED WITH MINIMAL FLOW ANESTHESIA: A PROSPECTIVE, RANDOMIZED STUDY', 'orgStudyIdInfo': {'id': '2/106 25.03.2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medium flow anesthesia', 'description': 'After reaching the MAC 1 value with 4lt/min 50% O2 - 50% air and 8% desflurane medium flow anesthesia was started with 2 lt/min 50% O2 - 50% air with MAC 1 concentration desflurane.', 'interventionNames': ['Other: Medium flow anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Minimal flow anesthesia', 'description': 'After reaching the MAC 1 value with 4 lt/min 50% O2 - 50% air and 8% desflurane minimal flow anesthesia was started with 0.50 lt/min 50% O2 - 50% air with MAC 1 concentration of desflurane.', 'interventionNames': ['Other: Minimal flow anesthesia']}], 'interventions': [{'name': 'Medium flow anesthesia', 'type': 'OTHER', 'description': 'Group MeFA; after reaching the MAC 1 value with 4lt/min 50% O2 - 50% air and 8% desflurane with remifentanil infusion, medium flow anesthesia was started with 2 lt/min 50% O2 - 50% air with MAC 1 concentration desflurane. The vaporizer was closed at the end of the last suture, and the flow was increased to 80% oxygen at 6 lt/min.', 'armGroupLabels': ['Medium flow anesthesia']}, {'name': 'Minimal flow anesthesia', 'type': 'OTHER', 'description': 'Group MiFA; after reaching the MAC 1 value with 4 lt/min 50% O2 - 50% air and 8% desflurane with remifentanil infusion, minimal flow anesthesia was started with 0.50 lt/min 50% O2 - 50% air with MAC 1 concentration of desflurane. The vaporizer was closed at the end of the last suture, and the flow was increased to 80% oxygen at 6 lt/min.', 'armGroupLabels': ['Minimal flow anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25080', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Erkan Cem ÇELİK', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Erkan Cem ÇELİK', 'investigatorAffiliation': 'Ataturk University'}}}}