Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-27 @ 3:16 AM
Study NCT ID:
NCT07027293
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-06-10', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insertion Time of Supraglottic Airway Device', 'timeFrame': '1-10 minutes'}, {'measure': 'Number of attempts for LMA replacement', 'timeFrame': '15-200 seconds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Supraglottic airway device', 'i-gel', 'Classic laryngeal mask airway', 'Elderly patients', 'Airway management', 'Head position', 'General anesthesia', 'Insertion success'], 'conditions': ['Airway Management Assessment', 'Supraglottic Airways', 'Supraglottic Airways for General Anesthesia', 'Laryngeal Mask Airways']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized, double-blind clinical study aims to evaluate the insertion success of two supraglottic airway devices, the classic Laryngeal Mask Airway (LMA) and the I-gel, in different head and neck positions in elderly patients undergoing elective urological surgery under general anesthesia. A total of 120 patients aged over 75 years with ASA physical status I-III will be randomly assigned to one of four groups: standard position with I-gel, right lateral rotation with I-gel, standard position with classic LMA, and right lateral rotation with classic LMA. The study will compare insertion time, ease and success of placement, number of attempts, hemodynamic responses, oropharyngeal leak pressures, fiberoptic scores, and airway-related complications. The findings aim to provide clinical guidance on the optimal use of supraglottic airway devices in geriatric patients in various head positions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA classification I-III\n* Age over 75 years\n\nExclusion Criteria:\n\n* Known or anticipated difficult airway\n* Contraindications for the use of a supraglottic airway device\n* Patients scheduled for endotracheal intubation'}, 'identificationModule': {'nctId': 'NCT07027293', 'briefTitle': 'The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'Evaluation of the Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients', 'orgStudyIdInfo': {'id': 'E-10840098-202.3.02-1265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard head position + i-gel', 'interventionNames': ['Other: STANDART HEAD POSITION', 'Device: i-gel supraglottic airway device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rotated head position + i-gel', 'interventionNames': ['Other: HEAD ROTATION POSITION', 'Device: i-gel supraglottic airway device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard head position + classic LMA', 'interventionNames': ['Other: STANDART HEAD POSITION', 'Device: Classic laryngeal mask airway (LMA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rotated head position + classic LMA', 'interventionNames': ['Other: HEAD ROTATION POSITION', 'Device: Classic laryngeal mask airway (LMA)']}], 'interventions': [{'name': 'STANDART HEAD POSITION', 'type': 'OTHER', 'description': 'STANDART HEAD POSITION', 'armGroupLabels': ['Standard head position + classic LMA', 'Standard head position + i-gel']}, {'name': 'HEAD ROTATION POSITION', 'type': 'OTHER', 'description': 'HEAD ROTATION POSITION', 'armGroupLabels': ['Rotated head position + classic LMA', 'Rotated head position + i-gel']}, {'name': 'Classic laryngeal mask airway (LMA)', 'type': 'DEVICE', 'description': 'Classic laryngeal mask airway (LMA)', 'armGroupLabels': ['Rotated head position + classic LMA', 'Standard head position + classic LMA']}, {'name': 'i-gel supraglottic airway device', 'type': 'DEVICE', 'description': 'i-gel supraglottic airway device', 'armGroupLabels': ['Rotated head position + i-gel', 'Standard head position + i-gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34230', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yadigar Yılmaz', 'role': 'CONTACT', 'email': 'dryadigaryilmaz@gmail.com', 'phone': '5053069924'}], 'facility': 'Yadigar Yılmaz', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Yadigar Yılmaz', 'investigatorAffiliation': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}}}}