Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT07041567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
İn This Study, Patients Undergoing Bariatric Surgery Will be Divided Into Two Groups. The Control Group Will Receive Normal-flow, While the Study Group Will Receive Low-flow Inhalational Anesthesia. The Aim is to Compare the Incidence of Postop Atelectasis-between the Two Groups Using USG Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-06-16', 'studyFirstSubmitQcDate': '2025-06-26', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the atelectasis rate with the Lung Ultrasound score (AUS score).', 'timeFrame': '8 months'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atelectasis', 'Pulmonary Complications', 'Ultrasonography']}, 'descriptionModule': {'briefSummary': 'This study is a clinical trial and its purpose is to evaluate the effect of low and normal flow anesthesia on atelectasis formation in patients undergoing bariatric surgery by ultrasonography.\n\nIn this study, lung ultrasounds and respiratory function tests will be performed on volunteers before and after surgery. These procedures are completely painless and safe.\n\nNo invasive procedure will be performed in the study; the methods used do not pose any additional risk other than existing treatment procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Will undergo Sleeve Gastrectomy surgery;\n* 18-65 years old\n* ASA III patients.\n\nExclusion Criteria:\n\n* Patients who do not give consent\n* Patients with ASA 4 and above\n* Those with serious respiratory comorbidities (interstitial lung disease, serious permanent lung diseases)\n* Uncontrolled Hypertension, Diabetes Mellitus\n* Under 18 and over 65 years of age\n* Chronic renal failure, Liver failure\n* CHF (EF\\<30) will not be included in the study'}, 'identificationModule': {'nctId': 'NCT07041567', 'acronym': 'BCAİA-AUD28', 'briefTitle': 'İn This Study, Patients Undergoing Bariatric Surgery Will be Divided Into Two Groups. The Control Group Will Receive Normal-flow, While the Study Group Will Receive Low-flow Inhalational Anesthesia. The Aim is to Compare the Incidence of Postop Atelectasis-between the Two Groups Using USG Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'THE EFFECT OF LOW-FLOW-ANESTHESİA ON POSTOPERATİVE ATELECTASİS İN PATİENTS UNDERGOİNG BARİATRİC SURGERY: AN EVALUATİON USİNG ULTRASOUND', 'orgStudyIdInfo': {'id': 'BCAİA-AUD28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group (group N) - Standard flow anesthesia', 'description': 'İnhalational anesthesia', 'interventionNames': ['Other: Inhalational anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'İntervention group (Group D) - Low Flow Anesthesia', 'description': 'İnhalational anesthesia', 'interventionNames': ['Other: Inhalational anesthesia']}], 'interventions': [{'name': 'Inhalational anesthesia', 'type': 'OTHER', 'otherNames': ['Normal flow inhalational anesthesia (Group N)', 'Low flow inhalational anesthesia (Group D)'], 'description': 'In Group D, patients undergoing bariatric surgery will receive low-flow inhalational anesthesia (0.5-1 L/min) with sevoflurane. The aim is to evaluate whether the reduced fresh gas flow rate decreases the incidence of postoperative atelectasis, assessed via pulmonary ultrasonography.\n\nIn Group N, patients undergoing bariatric surgery will receive standard-flow inhalational anesthesia (2-4 L/min) with sevoflurane. This group serves as the comparator to evaluate the impact of flow rate on postoperative atelectasis incidence.', 'armGroupLabels': ['Control group (group N) - Standard flow anesthesia', 'İntervention group (Group D) - Low Flow Anesthesia']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RESIDENT DOCTOR', 'investigatorFullName': 'Dunyakhanim Farzaliyeva', 'investigatorAffiliation': 'Goztepe Prof Dr Suleyman Yalcın City Hospital'}}}}