Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2025-12-24 @ 1:52 PM
Study NCT ID:
NCT06121895
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2023-10-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Differences in Video Laryngeal Mask Airway and Fastrack Laryngeal Mask
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-30', 'studyFirstSubmitDate': '2023-10-29', 'studyFirstSubmitQcDate': '2023-11-02', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Laryngeal Mask Placement times(minute)', 'timeFrame': '3 minutes after induction of anesthesia', 'description': 'Laryngeal Mask Placement times(minute)'}, {'measure': 'Intubation times', 'timeFrame': '3 minutes after induction of anesthesia', 'description': 'Intubation times'}, {'measure': 'Number of failed attempts', 'timeFrame': '3 minutes after induction of anesthesia', 'description': 'Number of failed attempts'}], 'secondaryOutcomes': [{'measure': 'Sore throat', 'timeFrame': '0-2-4-8-12-24 hours postoperatively', 'description': 'Postoperative complications'}, {'measure': 'Hoarseness', 'timeFrame': '0-2-4-8-12-24 hours postoperatively', 'description': 'Postoperative complications'}, {'measure': 'Nausea-vomiting', 'timeFrame': '0-2-4-8-12-24 hours postoperatively', 'description': 'Postoperative complications'}, {'measure': 'Need for additional antiemetic medication', 'timeFrame': '0-2-4-8-12-24 hours postoperatively', 'description': 'Postoperative complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fastrack Laryngeal Mask', 'Video Laryngeal Mask'], 'conditions': ['The Device Placement Times', 'Intubation Times', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '26556848', 'type': 'RESULT', 'citation': "Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10."}, {'pmid': '34919170', 'type': 'RESULT', 'citation': 'Van Zundert AAJ, Gatt SP, Van Zundert TCRV, Kumar CM, Pandit JJ. Features of new vision-incorporated third-generation video laryngeal mask airways. J Clin Monit Comput. 2022 Aug;36(4):921-928. doi: 10.1007/s10877-021-00780-3. Epub 2021 Dec 17.'}, {'pmid': '11684987', 'type': 'RESULT', 'citation': 'Ferson DZ, Rosenblatt WH, Johansen MJ, Osborn I, Ovassapian A. Use of the intubating LMA-Fastrach in 254 patients with difficult-to-manage airways. Anesthesiology. 2001 Nov;95(5):1175-81. doi: 10.1097/00000542-200111000-00022.'}, {'pmid': '40596865', 'type': 'DERIVED', 'citation': 'Ozguner Y, Ozagar UC, Kina SF, Sezgi A, Altinsoy S, Ergil J. Comparison of sacovlm video laryngeal mask-guided intubation and fastrach combined with flexible bronchoscopy-guided intubation -a prospective study. BMC Anesthesiol. 2025 Jul 1;25(1):315. doi: 10.1186/s12871-025-03172-1.'}]}, 'descriptionModule': {'briefSummary': 'In our study, patients who are intubated using VLM and Fastrack LMA for intubation purposes will be included. The placement times, intubation times, and the number of failed attempts for both devices will be recorded. Additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.', 'detailedDescription': 'The 2015 Difficult Airway Society guidelines specify that in cases where an unexpectedly difficult airway is encountered, and the initial intubation attempt is unsuccessful, the insertion of a supraglottic airway device (SAD) is recommended to maintain ventilation and oxygenation, followed by tracheal intubation through the SAD. SAD has been designated as a rescue airway device in difficult airway algorithms and resuscitation guidelines to "buy time." Additionally, SAD is used to maintain airway and anesthesia in surgeries that do not require intubation.\n\nThe Video Laryngeal Mask (VLM) is a newly developed type of SAD. With VLM, direct visualization of the glottis is achieved immediately after SAD placement. VLM has a channel that allows for endotracheal tube passage for intubation purposes and provides direct visualization. The Fastrack LMA, on the other hand, possesses all the ventilation features of classic SADs but is designed for blind or fiberoptic-guided tracheal intubations. These devices are used as rescue devices in cases of limited neck extension and difficult airway situations. Both devices are routinely used for ventilation and intubation purposes in patients. The use of these two devices is preferred in patients where neck extension is undesirable or neck movements are restricted for intubation purposes.\n\nIn our study, patients who are intubated using VLM and Fastrack LMA for intubation purposes will be included. The placement times, intubation times, and the number of failed attempts for both devices will be recorded. Additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Surgical patients undergoing elective surgery and intubated under general anesthesia.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals between the ages of 18 and 80.\n2. Patients with ASA (American Society of Anesthesiologists) scores I, II, or III.\n3. Patients undergoing surgery under general anesthesia in the operating room.\n\nExclusion Criteria:\n\n1. Patients under 18 years old or over 80 years old.\n2. Patients who refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06121895', 'briefTitle': 'Evaluation of Differences in Video Laryngeal Mask Airway and Fastrack Laryngeal Mask', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'Evaluation of Differences in Placement Success and Postoperative Complications Between Video Laryngeal Mask Airway and Fastrack Laryngeal Mask', 'orgStudyIdInfo': {'id': 'AnkaraEtlikYusufOzguner006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Video Laryngeal Mask', 'description': 'Patients who are intubated using Video Laryngeal Mask for intubation purposes will be included.', 'interventionNames': ['Other: Video Laryngeal Mask']}, {'label': 'Fastrack Laryngeal Mask', 'description': 'Patients who are intubated using Fastrack Laryngeal Mask for intubation purposes will be included.', 'interventionNames': ['Other: Fastrack Laryngeal Mask']}], 'interventions': [{'name': 'Video Laryngeal Mask', 'type': 'OTHER', 'description': 'Patients who are intubated using Video Laryngeal Mask for intubation purposes will be included.', 'armGroupLabels': ['Video Laryngeal Mask']}, {'name': 'Fastrack Laryngeal Mask', 'type': 'OTHER', 'description': 'Patients who are intubated using Fastrack Laryngeal Mask for intubation purposes will be included.', 'armGroupLabels': ['Fastrack Laryngeal Mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'state': 'Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Yusuf Ozguner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Etlik City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yusuf Özgüner', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}