Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT06237504
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of SAD insertion on first attempt.', 'timeFrame': 'Within the intraoperative period', 'description': "The success of SAD insertion is defined as when the a normal square-shaped capnography waveform is detected upon manual ventilation and symmetric movements of the patient's chest wall are observed."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elderly', 'Laryngeal Mask Airway', 'General Anesthesia']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether the use of a video LMA device (SacoVLM™) will facilitate successful supraglottic airway device (SAD) insertion compared to the use of a conventional 2nd generation SAD (Ambu®Auragain™) in elderly patients. This study is a randomized trail with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '95 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients 65 years of age or older, ASA class I\\~III, scheduled for elective surgery under general anesthesia under 2 hours, and eligible for SAD use for airway maintenance.\n\nExclusion Criteria:\n\nRefusal to participate, patients unable to read consent form, anticipated difficulty in face mask ventilation or airway management based on past history or anatomical structure, upper respiratory tract infection, airway-related diseases such as asthma or pneumonia, risk of gastroesophageal reflux'}, 'identificationModule': {'nctId': 'NCT06237504', 'briefTitle': 'The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)', 'orgStudyIdInfo': {'id': '1-2023-0081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ambu Auragain', 'description': 'Patients receiving general anesthesia with airway maintained with the 2nd generation SAD, Ambu Auragain.', 'interventionNames': ['Device: Ambu®Auragain™']}, {'type': 'EXPERIMENTAL', 'label': 'SaCoVLM', 'description': 'Patients receiving general anesthesia with airway maintained with the video LMA, SaCoVLM.', 'interventionNames': ['Device: SaCoVLM™']}], 'interventions': [{'name': 'SaCoVLM™', 'type': 'DEVICE', 'description': 'Patients will receive general anesthesia with their airways maintained with the SaCoVLM, which is a newer supraglottic airway device with a video port to directly visualize the upper airway.', 'armGroupLabels': ['SaCoVLM']}, {'name': 'Ambu®Auragain™', 'type': 'DEVICE', 'description': 'Patients will receive general anesthesia with their airways maintained with the Ambu Auragain, which is a conventional 2nd generation supraglottic airway device.', 'armGroupLabels': ['Ambu Auragain']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae Hoon Lee', 'role': 'CONTACT', 'email': 'neogens@yuhs.ac', 'phone': '82-2-2228-2418'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jae Hoon Lee', 'role': 'CONTACT', 'email': 'neogens@yuhs.ac', 'phone': '82-2-2228-2418'}], 'overallOfficials': [{'name': 'Jae Hoon Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}