Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT02570269
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2015-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Comparison of Oral Intubation Via - Ambu® Aura Gain™ vs Slotted Guedel Tubus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2015-09-23', 'studyFirstSubmitQcDate': '2015-10-06', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'Intraoperative', 'description': 'Time to complete the Intubation in seconds'}], 'secondaryOutcomes': [{'measure': 'Intubation attempts', 'timeFrame': 'Intraoperative', 'description': 'The number of intubation attempts will be recorded (eg 1, 2, 3...)'}, {'measure': 'Esophagal Intubation attempts', 'timeFrame': 'Intraoperative', 'description': 'The number of esophagal intubation attempts will be recorded (eg 1, 2, 3...)'}, {'measure': 'Resistance measurement of the Insertion as assessed by a four point scoring system', 'timeFrame': 'Intraoperative', 'description': '1/2/3/4'}, {'measure': 'Position of the mask as assessed by the Brimacombe Score', 'timeFrame': 'Intraoperative', 'description': '4/3/2/1'}, {'measure': 'Pain after Intubation as assessed by a Numeric Rating Scale', 'timeFrame': 'Intraoperative/2h postoperative/24h postoperative', 'description': 'mild/moderate/severe'}, {'measure': 'AE/Complications', 'timeFrame': 'Intraoperative/postoperative until 24h', 'description': 'Occuring AE/Complications will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adverse Anesthesia Outcome']}, 'referencesModule': {'references': [{'pmid': '28718101', 'type': 'DERIVED', 'citation': 'Moser B, Audige L, Keller C, Brimacombe J, Gasteiger L, Bruppacher HR. Flexible bronchoscopic intubation through the AuraGain laryngeal mask versus a slit Guedel tube: a non-inferiority randomized-controlled trial. Can J Anaesth. 2017 Nov;64(11):1119-1128. doi: 10.1007/s12630-017-0936-7. Epub 2017 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18\n* ASA 1 -2\n* Surgery of the shoulder, elbow, hand, hip, knee or foot\n* Signed consent form\n\nExclusion Criteria:\n\n* Patients with expected difficulties regarding to the intubation\n* Patients with diseases / anatomical changes in the area of the pharynx, the larynx, the trachea, the esophagus or the stomach\n* Not sober\n* Increased risk of aspiration\n* BMI \\> 35 kg/m2\n* Acute disease which could affect the suitability of the anesthesia\n* Patients in which the use of a laryngeal mask is contraindicated or otherwise not possible\n* Patients with a disease which prevents an accurate examination of the patients (eg neuromuscular, mentally, metabolic disease)\n* Drug abuse in the recent past\n* Legal incompetence'}, 'identificationModule': {'nctId': 'NCT02570269', 'briefTitle': 'Prospective Comparison of Oral Intubation Via - Ambu® Aura Gain™ vs Slotted Guedel Tubus', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'Prospective Randomized Comparison Between a Flexible Fiberoptic Intubation Via the Ambu® Aura Gain™ Airway and the Slotted Guedel Tubus in Terms of Time to a Completed Airway Management and Patient Safety.', 'orgStudyIdInfo': {'id': 'Schulthess_Anä_6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AuraGain', 'description': 'The patient will get a fiberoptic Intubation via the AuraGain larynxmask', 'interventionNames': ['Procedure: AuraGain']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Slotted Guedeltubus', 'description': 'The patient will get a fiberoptic intubation via the slotted Guedeltubus', 'interventionNames': ['Procedure: Slotted Guedeltubus']}], 'interventions': [{'name': 'AuraGain', 'type': 'PROCEDURE', 'description': 'Fiberoptic Intubation', 'armGroupLabels': ['AuraGain']}, {'name': 'Slotted Guedeltubus', 'type': 'PROCEDURE', 'description': 'Fiberoptic Intubation', 'armGroupLabels': ['Slotted Guedeltubus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Schulthess Klinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Berthold Moser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schulthess Klinik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Berthold Moser', 'investigatorAffiliation': 'Schulthess Klinik'}}}}