Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-01 @ 9:49 PM
Study NCT ID:
NCT03147469
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2017-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Head and Neck Position on Performance of Ambu AuraGain™
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': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.\n\nThe expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.\n\nFiberoptic bronchoscopic view will be also assessed for each head and neck positions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-26', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-08', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oropharyngeal leak pressure', 'timeFrame': '30 seconds after positioning of head and neck', 'description': "The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate was fixed at 3 L/min."}], 'secondaryOutcomes': [{'measure': 'Peak inspiratory pressure', 'timeFrame': '30 seconds after positioning of head and neck', 'description': 'Peak inspiratory pressure'}, {'measure': 'Expiratory tidal volume', 'timeFrame': '30 seconds after positioning of head and neck', 'description': 'Expiratory tidal volume'}, {'measure': 'Ventilation score', 'timeFrame': '30 seconds after positioning of head and neck', 'description': 'No leakage with an airway pressure of 15cmH2O; bilateral chest excursion with a peak inspiratory pressure of 20cmH2O; and a square-wave capnogram'}, {'measure': 'Fiberoptic score', 'timeFrame': '30 seconds after positioning of head and neck', 'description': '1, vocal cords not visible; 2, vocal cords plus anterior epiglottis visible; 3, vocal cords plus posterior epiglottis visible; 4, only vocal cords visible'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Anesthesia']}, 'descriptionModule': {'briefSummary': 'The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated.\n\nThis study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway.\n\nAuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.\n\nThe expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.\n\nFiberoptic bronchoscopic view will be also assessed for each head and neck positions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults who were to undergo elective surgery under general anaesthesia using supraglottic airway device\n\nExclusion Criteria:\n\n* Patients who had risk factor for difficult intubation\n* BMI \\> 30kg/m2\n* Emergency operation without NPO\n* History of cervical spine surgery or disease\n* History of esophageal operation or gastroesophageal reflux disease'}, 'identificationModule': {'nctId': 'NCT03147469', 'briefTitle': 'The Influence of Head and Neck Position on Performance of Ambu AuraGain™', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Influence of Head and Neck Position on Performance of Ambu AuraGain™', 'orgStudyIdInfo': {'id': 'H-1704-068-844'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Neutral', 'description': 'After insertion of Ambu AuraGain™, the variables will be assessed at each positions including neutral, flexion, extension, right rotation under random order.'}, {'type': 'EXPERIMENTAL', 'label': 'Flexion', 'description': "After positioning the subjects' neck to flexion, the variables will be assessed.", 'interventionNames': ['Procedure: Flexion']}, {'type': 'EXPERIMENTAL', 'label': 'Extension', 'description': "After positioning the subjects' neck to extension, the variables will be assessed.", 'interventionNames': ['Procedure: Extension']}, {'type': 'EXPERIMENTAL', 'label': 'Right rotation', 'description': "After positioning the subjects' head to right rotation, the variables will be assessed.", 'interventionNames': ['Procedure: Right rotation']}], 'interventions': [{'name': 'Flexion', 'type': 'PROCEDURE', 'description': 'After changing the position of head and neck of subjects to flexion, the variables were measured.', 'armGroupLabels': ['Flexion']}, {'name': 'Extension', 'type': 'PROCEDURE', 'description': 'After changing the position of head and neck of subjects to extension, the variables were measured.', 'armGroupLabels': ['Extension']}, {'name': 'Right rotation', 'type': 'PROCEDURE', 'description': 'After changing the position of head and neck of subjects to right flexion, the variables were measured.', 'armGroupLabels': ['Right rotation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}