Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT06177769
Status:
COMPLETED
Last Update Posted:
2025-05-11
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Supraglottic Airway Devices in EBUS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of fiberoptic view', 'timeFrame': '3 minutes after anesthesia induction', 'description': 'The operator will score the view of the glottic opening according to the Cormack Lehanne score'}], 'secondaryOutcomes': [{'measure': 'Ease of passage through glottic opening', 'timeFrame': '3 minutes after anesthesia induction', 'description': 'The operator will score theEase of passage through glottic opening according to a Likert scale'}, {'measure': 'Ease of SAD insertion', 'timeFrame': '2 minutes after anesthesia induction', 'description': 'The anesthetist will score the ease of SAD insertion a 5 point scale'}, {'measure': 'Complications', 'timeFrame': '1 minute after extubation', 'description': 'Airway trauma as indicated with blood stain on SAD or visible bleeding in the airway'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Airway management', 'Lung diseases'], 'conditions': ['Airway Management', 'Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '27555181', 'type': 'BACKGROUND', 'citation': 'Maitra S, Baidya DK, Arora MK, Bhattacharjee S, Khanna P. Laryngeal mask airway ProSeal provides higher oropharyngeal leak pressure than i-gel in adult patients under general anesthesia: a meta-analysis. J Clin Anesth. 2016 Sep;33:298-305. doi: 10.1016/j.jclinane.2016.04.020. Epub 2016 May 18.'}, {'pmid': '33687002', 'type': 'BACKGROUND', 'citation': 'Goel MK, Kumar A, Maitra G, Singh B, Ahlawat S, Jain P, Garg N, Verma RK. Safety and diagnostic yield of transbronchial lung cryobiopsy by flexible bronchoscopy using laryngeal mask airway in diffuse and localized peripheral lung diseases: A single-center retrospective analysis of 326 cases. Lung India. 2021 Mar-Apr;38(2):109-116. doi: 10.4103/lungindia.lungindia_220_20.'}]}, 'descriptionModule': {'briefSummary': 'Supraglottic airway devices (SAD) provide ventilation of patients requiring respiratory support without tracheal intubation. Therefore, SAD is used to maintain airway during anesthesia in surgeries that do not require intubation. The classical laryngeal mask (cLMA, Intavent Direct, Maidenhead, UK) is an SAD that is available as a more advanced airway method than mask ventilation and a less invasive method than endotracheal intubation. It is used by placing it over the glottis at the level of the larynx and inflating the cuff. The Proseal laryngeal mask (LMA-Proseal™, PLMA, Intavent Orthofix, Maidenhead, UK) is the first supraglottic airway device that is suitable for reuse and includes a gastric drainage channel. I-gel™ (Intersurgical Ltd, Wokingham, UK) is a second-generation laryngeal mask with a soft, gel-like thermoplastic elastomer distal end and no inflatable cuff, designed not to compress the anatomical structures of the larynx and pharynx.\n\nEndobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) has become one of the most important invasive diagnostic procedures for pulmonologists and thoracic surgeons. It is a safe and effective technique for sampling hilar and mediastinal lymph nodes and masses. It is currently accepted as the first choice for histological sampling of the mediastinum in lung cancer staging.\n\nThe use of SAD to secure the airway in patients undergoing EBUS-TBNA has the advantages of being less invasive than endotracheal intubation and providing better surgical field access.\n\nClassical LMA, proseal LMA and I-gel are routinely used airway methods during EBUS-TBNA procedure.\n\nThe aim of this study is to compare the routinely used SADs in anesthesia management in patients undergoing endobronchial ultrasonography-guided transbronchial needle aspiration in terms of intraoperative efficacy and postoperative complications.', 'detailedDescription': 'The parameters to be recorded are: demographic characteristics of the patients, hemodynamic data during and after the procedure, ventilation variables (tidal volume, airway pressures, leak volume), the number of attempts to place the SAD, the need for intubation, the presence of sore throat, nausea and vomiting after the procedure. In addition, the operator performing the procedure will be asked to evaluate the convenience of the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing Endobronchial ultrasound guided transbronchial needle aspiration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults ageing 18-80 years\n* patients in ASA phyical class\n* patients undergoing Endobronchial ultrasound guided transbronchial needle aspiration\n\nExclusion Criteria:\n\n* patients undergoing emergent procedure\n* pediatric patients\n* patients having upper airway pathology\n* patients in risk of aspiration'}, 'identificationModule': {'nctId': 'NCT06177769', 'acronym': 'SAD-EBUS', 'briefTitle': 'Comparison of Supraglottic Airway Devices in EBUS', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'Comparison of Efficacy and Complications of Three Supraglottic Airway Devices in Endobronchial Ultrasonographic Transbronchial Needle Aspiration Anesthesia', 'orgStudyIdInfo': {'id': 'SAD-EBUS Derya'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Airway is secured with LMA classic', 'interventionNames': ['Device: LMA classic']}, {'label': 'Group II', 'description': 'Airway is secured with LMA proseal', 'interventionNames': ['Device: LMA Proseal']}, {'label': 'Group III', 'description': 'Airway is secured with I-gel', 'interventionNames': ['Device: I-gel']}], 'interventions': [{'name': 'LMA classic', 'type': 'DEVICE', 'description': 'Airway is secured with LMA clasic', 'armGroupLabels': ['Group I']}, {'name': 'LMA Proseal', 'type': 'DEVICE', 'description': 'Airway is secured with LMA proseal', 'armGroupLabels': ['Group II']}, {'name': 'I-gel', 'type': 'DEVICE', 'description': 'Airway is secured with I-gel', 'armGroupLabels': ['Group III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Derya Güzelkaya, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Etlik City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Derya Guzelkaya', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}