Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 6:20 PM
Study NCT ID:
NCT01496859
Status:
COMPLETED
Last Update Posted:
2012-03-26
First Post:
2011-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Baska Mask, a New Supraglottic Airway Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016254', 'term': 'Mutagenesis, Insertional'}], 'ancestors': [{'id': 'D015202', 'term': 'Protein Engineering'}, {'id': 'D005818', 'term': 'Genetic Engineering'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009154', 'term': 'Mutation'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D016296', 'term': 'Mutagenesis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2011-12-18', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device Placement Success rate', 'timeFrame': 'within 30 mins of anaesthesia commencement'}, {'measure': 'time to placement of device', 'timeFrame': 'within 30 mins of anaesthesia commencement', 'description': 'from the moment the device touched until successful ventilation achieved or device removed'}], 'secondaryOutcomes': [{'measure': 'airway leak pressure of the device', 'timeFrame': 'within 30 mins of anaesthetic commencement'}, {'measure': 'user-rated ease of insertion of device', 'timeFrame': 'within 30 mins of anaestesia commencement', 'description': '10cm visual analog score to be used'}, {'measure': 'complication rates', 'timeFrame': 'From the moment general anaesthesia commenced up to 1 day postoperatively', 'description': 'complications specifically monitored will be desaturation episodes, laryngospasm, blood staining of the device, lip damage. We will record other complications related to the use of the device, including but not limited to loss of airway with need to manioulate mask/switch to alternative device, regurgitation, aspiration, teeth damage.'}, {'measure': 'patient comfort indices', 'timeFrame': 'from the moment the patient awake up to 1 day postoperatively', 'description': 'Throat pain, dysphagia and dysphonia will be assessed. 10 point verbal rating scale will be used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Baska mask', 'supraglottic airway', 'airway management'], 'conditions': ['Performance and Safety of a New Supraglottic Airway Device']}, 'descriptionModule': {'briefSummary': 'The Baska mask is a new supraglottic airway device . The investigators would like to assess its performance in setting in which the current standard - LMA device - is being used.', 'detailedDescription': 'Our group has performed a number of studies on novel airway devices. In this study we would like to evaluate a new supraglottic airway named Baska mask. We would like to monitor certain parameters (time to and ease of insertion, failure rate, seal pressures, complications etc) as regarding the performance and safety profile of this device. This is a descriptive case series of patients undergoing airway management under general anaesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed Consent\n* No relevant drug allergies\n* Body-mass index (BMI) 20-35\n* Age 18-65\n* Non-urgent surgery of planned duration 0-2 hrs\n\nExclusion Criteria:\n\n* Inability of patient/parent to understand or consent for the trial\n* Non-English speakers\n* Neck pathology\n* Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days etc)\n* BMI \\>35\n* Expected Difficult airway\n* Live Pregnancy\n* Increased risk for Gastric Aspiration'}, 'identificationModule': {'nctId': 'NCT01496859', 'briefTitle': 'Observational Study of Baska Mask, a New Supraglottic Airway Device', 'organization': {'class': 'OTHER', 'fullName': 'University College Hospital Galway'}, 'officialTitle': 'Observational Study of Baska Mask, a New Supraglottic Airway Device', 'orgStudyIdInfo': {'id': 'C.A.621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baska', 'interventionNames': ['Device: Placement and use of Baska mask']}], 'interventions': [{'name': 'Placement and use of Baska mask', 'type': 'DEVICE', 'otherNames': ['Baska mask'], 'description': 'use of a supraglottic airway device as a standard part of a general anaesthetic', 'armGroupLabels': ['Baska']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Galway', 'state': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospitals', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}], 'overallOfficials': [{'name': 'John G Laffey, FFARCSI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Ireland, Galway and Galway University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Hospital Galway', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anaesthesia and Critical Care, Consultant Anaesthetist', 'investigatorFullName': 'John Laffey', 'investigatorAffiliation': 'University College Hospital Galway'}}}}