Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 5:49 PM
Study NCT ID:
NCT04421261
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2020-06-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ventilation With Supraglottic Airway Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oropharyngeal leak pressure', 'timeFrame': '1 year', 'description': 'pressure at which air leak starts to occur'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laryngeal Masks Comparison']}, 'descriptionModule': {'briefSummary': 'Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult female patients who will be admitted through outpatient clinic of Kasr alainy hospitals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female patients ASA I\\&II.\n* age: 18-55 years old.\n* BMI\\< 35.\n* undergoing elective surgeries.\n\nExclusion Criteria:\n\n* Patients with history of upper respiratory tract infections and obstructive sleep apnea.\n* Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \\&heart burn, those with esophageal reflux or hiatus hernia.\n* Patients with coagulation disorders.\n* Patients with El-Ganzouri airway score ≥ 5 will.'}, 'identificationModule': {'nctId': 'NCT04421261', 'briefTitle': 'Ventilation With Supraglottic Airway Devices', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Performance of Air-Q Self Pressurized Airway Device With Blocker and Proseal Laryngeal Mask Airway at Different Head and Neck Positions in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations', 'orgStudyIdInfo': {'id': 'KR-1990'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Air-Q Self Pressurized Airway Device with Blocker', 'interventionNames': ['Device: Air-Q Self Pressurized Airway Device with Blocker']}, {'label': 'Proseal Laryngeal Mask Airway', 'interventionNames': ['Device: Proseal Laryngeal Mask Airway']}], 'interventions': [{'name': 'Air-Q Self Pressurized Airway Device with Blocker', 'type': 'DEVICE', 'description': 'used in low risk adult females undergoing elective surgeries', 'armGroupLabels': ['Air-Q Self Pressurized Airway Device with Blocker']}, {'name': 'Proseal Laryngeal Mask Airway', 'type': 'DEVICE', 'description': 'used in low risk adult female patients undergoing elective surgeries', 'armGroupLabels': ['Proseal Laryngeal Mask Airway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Department of anesthesia, Surgical ICU and Pain Management', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reham Ali Abdelhaleem Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Anesthesia lecturer', 'investigatorFullName': 'Reham Ali Abdelhaleem Abdelrahman', 'investigatorAffiliation': 'Cairo University'}}}}