Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-01 @ 5:31 PM
Study NCT ID:
NCT05363566
Status:
UNKNOWN
Last Update Posted:
2022-05-06
First Post:
2022-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2022-03-19', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insertion time', 'timeFrame': '1 hour', 'description': "To determine the time taken for insertion of the device. (It will be calculated from the time of the mask will be taken away from the patient's face till the moment of the appearance of square wave capnography upstroke with the presence of sufficient ventilation) (second )"}], 'secondaryOutcomes': [{'measure': 'Ease of device insertion', 'timeFrame': '1 hours', 'description': 'will be graded using a five-point scoring system (4 = insertion at first attempt without tactile resistance, 3 = insertion at first attempt with little tactile resistance, 2 = insertion at first attempt with significant tactile resistance, 1 = insertion successful at second/third attempt, 0 = insertion failed at three attempts).'}, {'measure': 'Oropharyngeal leak pressures', 'timeFrame': '1 hours', 'description': 'Oropharyngeal leak pressures (OLPs) will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Baska Mask']}, 'descriptionModule': {'briefSummary': 'The Baska mask (proact Medical Ltd, Northants, UK) is the latest addition to an era of supraglottic airway devices in clinical use. It is made of medical grade silicone; it has many advantages in its constructions over other LMA, a cuff less membranous bowl in which the saliva secretion collected. An inbuilt "tab" that allows to extend its angulation for straightforward negotiation of the oropharyngeal curve during placement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion criteria\n\n 1. Adult patients from 18 to 60 years of age.\n 2. American Society of Anesthesiologists (ASA) physical status I and II\n 3. Both genders\n 4. Patients scheduled for elective surgeries lasting less than 2 hours under general anesthesia on spontaneous ventilation.\n 5. El Ganzouri index Score ≥ 4\n 6. Patients with BMI \\< 35 kg/m2\n* Exclusion criteria\n\n 1. The patients who will be refusal or inability to give informed consent,\n 2. ASA class III or IV\n 3. El Ganzouri index Score \\< 4,\n 4. Oropharyngeal pathology making a proper SAD fit unlikely as weak dentation, neck pathology\n 5. Respiratory illness including upper respiratory infection or pneumonia within the six weeks preceding surgery\n 6. Risk for gastric aspiration (e.g., hiatus hernia, gastro-oesophageal reflux disease or non-fasting status), expected duration of surgery longer than 2 h\n 7. Contraindication to SGA use including morbid obesity (body mass index 35 kg m-1, history of obstructive sleep apnea)\n 8. Any condition for which the primary anesthesia team deemed intubation with a tracheal tube to be necessary.'}, 'identificationModule': {'nctId': 'NCT05363566', 'briefTitle': 'Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Performance of the Baska MaskⓇ, the I-GelⓇ and the Self-Pressurized Air-QⓇ i', 'orgStudyIdInfo': {'id': 'N-49-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group I', 'description': 'will be inserted Single use supraglottic airway ( Baska mask® (proact Medical Ltd, Northants, UK)', 'interventionNames': ['Device: airway divice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group II', 'description': 'will be inserted Single use supraglottic airway ( I-gel® ) (Intersurgical Ltd, Wokingham, Berkshire, UK)', 'interventionNames': ['Device: airway divice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group III (SP Air-Q) (n = 26)', 'description': 'will be inserted Single use supraglottic airway (self-pressurized Air-Q intubating laryngeal airway (Air-Q SP®)) (Mercury Medical, Clearwater, FL, USA)', 'interventionNames': ['Device: airway divice']}], 'interventions': [{'name': 'airway divice', 'type': 'DEVICE', 'description': 'inserted airway device', 'armGroupLabels': ['group I', 'group II', 'group III (SP Air-Q) (n = 26)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'still working'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amr Samir Wahdan', 'investigatorAffiliation': 'Cairo University'}}}}