Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT07107893
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2025-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Double Lumen Tube Location Verification Techniques in Single Lung Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-04', 'size': 117971, 'label': 'Study Protocol: RESEARCH PROTOCOL', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-02T12:19', 'hasProtocol': True}, {'date': '2024-11-04', 'size': 62711, 'label': 'Statistical Analysis Plan: STATISTICAL ANALYSIS', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-02T12:21', 'hasProtocol': False}, {'date': '2024-11-04', 'size': 129475, 'label': 'Informed Consent Form: INFORMED VOLUNTARY CONSENT FORM', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-02T12:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cost effectiveness', 'timeFrame': 'during surgery', 'description': 'The other endpoint is to determine the superiority of the three methods over each other in terms of reducing costs.'}], 'primaryOutcomes': [{'measure': 'verification of tube location', 'timeFrame': 'during surgery', 'description': 'The primary endpoint is the identification of a method that allows the quickest confirmation of double-lumen tube location after intubation and possible intraoperative location changes.'}], 'secondaryOutcomes': [{'measure': 'evaluation of complications', 'timeFrame': 'during surgery', 'description': 'The secondary endpoint was to determine the superiority of three methods over each other in preventing complications that may occur due to inadequate tube location confirmation.'}]}, 'conditionsModule': {'keywords': ['Double lumen tube with video', 'Single lung ventilation'], 'conditions': ['Lung Cancer', 'Lung Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare auscultation, fiberoptic bronchoscopy (FOB) and video double lumen tube (VDLT) double lumen tube (DLT) location confirmation techniques in terms of intraoperative tube location confirmation time, number of tube dislocations, correction time of dislocations, FOB usage rates, lung deflation quality, postoperative sore throat, presence of hoarseness and cost in thoracic surgery patients undergoing one lung ventilation (OLV).', 'detailedDescription': 'The single-center, prospective and observational study included 93 patients aged 18-84 years, American Society of Anesthesiology (ASA) I-III, who were to undergo one-lung ventilation in the lateral decubitus position by thoracic surgery under elective conditions. Patients were randomized into Group I: Group with confirmed tube location by auscultation, Group II: Group with confirmed tube location by FOB and Group III: The group in which double lumen tube with video was used. Demographic data of the patients, intubation times, tube site confirmation times, number of type dislocation, dislocation correction time, number and duration of FOB use, quality of lung deflation, presence of postoperative sore throat and hoarseness were recorded. The three groups were compared in terms of cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Ninety-three patients who would undergo thoracic surgery with single-lung ventilation at the Health Sciences University Kayseri City Training and Research Hospital Anesthesiology and Reanimation Clinic were evaluated for suitability.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will undergo TAV and be placed in the lateral position.\n* Patients with ASA scores of I-III.\n* Patients aged 18-84.\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery\n* Patients with American Society of Anesthesiology (ASA) IV and above\n* Patients with anticipated difficult intubation\n* Patients requiring intubation with a right thoracic duct (CLT)\n* Patients with more than three intubation attempts\n* Patients who refuse to participate in the study\n* Patients who will undergo TAV but will not be placed in the lateral position (sympathectomy)\n* Patients with uncontrolled metabolic disease\n* Mentally retarded patients\n* Patients under 18 or over 84\n* Patients with tracheal or airway abnormalities\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT07107893', 'briefTitle': 'Comparison of Double Lumen Tube Location Verification Techniques in Single Lung Ventilation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri City Hospital'}, 'officialTitle': 'Comparison of Double Lumen Tube Location Verification Techniques in Single Lung Ventilation: Auscultation, Fiberoptic Bronchoscopy, and Video Double Lumen Tube', 'orgStudyIdInfo': {'id': '2024-KEAK-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'grup I', 'description': 'Group with confirmed tube location by auscultation'}, {'label': 'Grup II', 'description': 'Group with confirmed tube location by fiberoptic bronchoscope'}, {'label': 'Grup III', 'description': 'The group in which double lumen tube with video was used', 'interventionNames': ['Device: double lumen tube with video']}], 'interventions': [{'name': 'double lumen tube with video', 'type': 'DEVICE', 'otherNames': ['fiberoptic bronchoscope'], 'description': 'Methods used to confirm tube placement in one-lung ventilation: auscultation, fiberoptic bronchoscopy, and video to evaluate double-lumen tube use', 'armGroupLabels': ['Grup III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38080', 'city': 'Kayseri', 'state': 'Kocasinan', 'country': 'Turkey (Türkiye)', 'facility': 'Kayseri Şehir Hastanesi', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant doctor of anesthesiology and reanimation', 'investigatorFullName': 'Arzu Fırat Durbilmez', 'investigatorAffiliation': 'Kayseri City Hospital'}}}}