Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-20 @ 4:35 AM
Study NCT ID:
NCT04253795
Status:
SUSPENDED
Last Update Posted:
2020-04-30
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017214', 'term': 'Laryngeal Masks'}], 'ancestors': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008397', 'term': 'Masks'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'not recruiting, awaiting for changes in IRB', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-02-01', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in PaO2/FiO2 ratio at the end of the surgery', 'timeFrame': '1 hour', 'description': 'PaO2/FiO2 ratio will be calculated for both groups at the end of the surgery'}], 'secondaryOutcomes': [{'measure': 'Anesthesia time', 'timeFrame': '20 minutes', 'description': 'Anesthesia time will be defined in minute as the time from starting electronically monitored in the operating room until the time the double lumen tube or laryngeal mask was correctly placed'}, {'measure': 'Operating room time', 'timeFrame': '1 hour', 'description': 'Operating room time will be defined in minute as the time from arrival to operating room until the patient will be transferred to the post anesthetic care unit.'}, {'measure': 'Post anesthetic care unit (PACU) time', 'timeFrame': '30 minutes', 'description': 'PACU time will be defined in minute as the time from arrival to the PACU until the patient was discharged to the ward.'}, {'measure': 'Surgeon satisfaction', 'timeFrame': '10 minutes', 'description': 'Surgeon will be asked to rate his satisfaction with the surgical conditions using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").'}, {'measure': 'Patient satisfaction', 'timeFrame': '10 minutes', 'description': 'Patient will be asked to rate his satisfaction using a 4-point Likert scale (ie, "4: excellent", "3: good", "2: satisfactory", "1: unsatisfactory").'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare to the patients undergoing nonintubated general anesthesia with laryngeal mask and undergoing intubated general anesthesia with double-lumen endotracheal intubation in Video-assisted thoracic surgery (VATS).', 'detailedDescription': 'Although general anesthesia with double-lumen intubation is generally mandatory for Video-assisted thoracic surgery procedures intubation with double lumen tube is related to several risks. Nonintubated general anesthesia with laryngeal mask in patients with spontaneous breathing may be an alternative choice for minor VATS procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective minor VATS procedures will be enrolled the study\n\nExclusion Criteria:\n\n* patients \\<18 years old,\n* body mass index (BMI)\\>30 kg/m2,\n* American Society Association (ASA) Class\\>3,\n* heart failure (New York Heart Association class \\> II),\n* a history of arrhythmia or treatment with antiarrhythmic drugs,\n* bradycardia (heart rate (HR) \\<45 beats min1)\n* atrioventricular block,\n* hepatic or renal dysfunction,\n* coagulopathy,\n* asthma\n* sleep apnea syndrome'}, 'identificationModule': {'nctId': 'NCT04253795', 'briefTitle': 'Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'Comparative Study of Nonintubated Anesthesia With Laryngeal Mask Versus Intubated Anesthesia With Double Lumen Tube in Video-assisted Thoracic Surgery', 'orgStudyIdInfo': {'id': 'AntalyaTRH030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laryngeal mask group (Group 1)', 'description': "Laryngeal mask will be placed in the airway by the anesthesiologist. Lung isolation will be achieved with an artificial pneumothorax induced during opening the pleura, which resulted to the collapse of the nondependent lung with the patient's spontaneous breathing", 'interventionNames': ['Other: Laryngeal mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Double lumen tube Group (Group 2)', 'description': 'After the correct position of double lumen tube will be determined, one lung ventilation will be started. Lung isolation will be achieved by deflation of the nondependent lung.', 'interventionNames': ['Other: double lumen tube']}], 'interventions': [{'name': 'Laryngeal mask', 'type': 'OTHER', 'description': "After the laryngeal mask will be inserted lung isolation will be achieved with an artificial pneumothorax induced during opening the pleura, which resulted to the collapse of the nondependent lung with the patient's spontaneous breathing.", 'armGroupLabels': ['Laryngeal mask group (Group 1)']}, {'name': 'double lumen tube', 'type': 'OTHER', 'description': 'After the one lung ventilation will be started, lung isolation will be achieved by deflation of the nondependent lung.', 'armGroupLabels': ['Double lumen tube Group (Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Ali Sait Kavakli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Training and Research Hospital'}, {'name': 'Tayfun Sugur, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Antalya Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}