Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-02 @ 8:02 AM
Study NCT ID:
NCT01753635
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
2012-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-15', 'studyFirstSubmitDate': '2012-12-17', 'studyFirstSubmitQcDate': '2012-12-17', 'lastUpdatePostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of successful placement of the supraglottic device on first attempt', 'timeFrame': 'within 30 minutes of commencement of general anesthesia', 'description': 'The hypothesis is that the Baska mask will have first time placement attempt success rate that is no more than 15% less than that of the comparator - a single use LMA device.'}, {'measure': 'Seal pressure of the supraglottic device', 'timeFrame': 'Within 30 minutes of commencement of general anesthesia', 'description': 'The investigators will measure the airway seal provided by the device used. The hypothesis is that the seal pressure of the Baska mask is 20% higher than that of the comparator single-use LMA device.'}], 'secondaryOutcomes': [{'measure': 'Overall rate of successful placement of the supraglottic device', 'timeFrame': 'Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed.'}, {'measure': 'Number of device placement attempts', 'timeFrame': 'Within 30 minutes of commencement of general anesthesia'}, {'measure': 'Number of optimization maneuvers during device placement', 'timeFrame': 'Within 30 minutes of commencement of general anesthesia'}, {'measure': 'user rated Device difficulty score', 'timeFrame': 'within 30 minutes of commencement of general anesthesia', 'description': 'the investigators will use 10 cm visual analogue scale to score the whole experience of using the device until successful ventilation is achieved.'}, {'measure': 'vitals parameter stability', 'timeFrame': 'in the period immediately before and within the first 35 minutes of general anesthesia', 'description': 'The investigators will record non-invasive arterial oxygen saturation, heart rate and blood pressure preoperatively, after induction of general anesthesia and after placement of the airway device.'}, {'measure': 'Laryngeal view obtained on fiberoptic assessment', 'timeFrame': 'within 2 hours of commencement of general anesthesia', 'description': 'The investigators will perform this when feasible.'}, {'measure': 'Complication rates', 'timeFrame': 'from the moment general anesthesia commenced up to 3 days postoperatively', 'description': 'Complications specifically monitored will be: blood staining, laryngospasm, lip damage, throat pain, dysphagia, dysphonia, heartburn, nausea and vomiting.\n\nThe investigators will record other complications related to the use of the device, including but not limited to: desaturation, need to reposition device or switch to alternative device, teeth damage, regurgitation, aspiration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Baska mask', 'LMA', 'single use LMA device', 'laryngeal mask airway', 'supraglottic airway device'], 'conditions': ['Performance and Safety of an Airway Management Device']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients.\n\nThe investigators have performed a number of studies on novel airway devices, including 3 studies on the Baska mask. This trial will compare some performance characteristics of the studied devices, including airway seal pressures, insertion success rates, device use difficulty scores. Additional performance and device safety data will be accumulated.\n\nThe investigators have two primary hypotheses, namely 1.Non-inferiority of first placement attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask vs LMA.', 'detailedDescription': "Supraglottic airway devices have established place in the airway management in patients undergoing general anesthesia.\n\nThe Baska mask is a new supraglottic airway device. It's features include:\n\n1. Non pressurized cuff designed to reduce the risk of oropharyngeal tissue damage.\n2. Improved cuff seal during the inspiratory phase of positive pressure ventilation\n3. An improved system for drainage of oropharyngeal contents intended to reduce the rate of lung aspiration.\n4. Integrated bite-block to reduce the risk of patients biting and blocking the airway.\n\nThis study is randomized, single-blinded, controlled trial. The participants will be allocated to two groups, in which either the Baska mask or the single use LMA will be the primary airway management device.\n\nClinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.\n\nStandard anesthetic preassesment and anesthesia will be provided.\n\nConsenting patients will be randomly allocated to either of the 2 study groups.\n\nProtocol for airway size selection and attempts at placement will be followed.\n\nThe investigators will monitor a number of parameters, including time and ease of insertion, airway seal pressure, airway leak, complications related to device use and other.\n\nFollow up will be performed.\n\nThe investigators have two primary hypotheses:\n\n1. That the Baska mask is non-inferior to LMA in respect if first placement attempt success rate. A greater than 15% difference in success rate will be considered a clinically important difference and will disprove this hypothesis.\n2. The Baska mask is superior in respect of seal pressure. A 20% higher seal pressure with Baska as compared to the LMA device seal pressure will be considered a clinically important difference.\n\nInterim analysis will be performed once 75 patients are recruited per group. This is reasonable as this figure exceeds that required to prove or disprove the primary hypothesis regarding the seal pressure. The study will only be stopped at this stage if the non-inferiority hypothesis is disproven with P value \\< 0.01\n\nIn addition to the above the investigators will evaluate a number of secondary outcomes."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Written informed consent\n* ASA 1-3\n* No relevant allergies\n* Body-mass index (BMI) 35 or less\n* Age 16-85\n* Non-urgent surgery of planned duration under 4 hours\n\nExclusion Criteria:\n\n* Inability of patient/parent to understand or consent for the trial\n* Neck pathology\n* Previous or anticipated problems with the upper airway or upper GI tract\n* BMI \\>35\n* Predicted or previously documented difficult airway\n* Live Pregnancy\n* Increased risk for Gastric Aspiration'}, 'identificationModule': {'nctId': 'NCT01753635', 'briefTitle': 'Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients', 'organization': {'class': 'OTHER', 'fullName': 'University College Hospital Galway'}, 'officialTitle': 'Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients', 'orgStudyIdInfo': {'id': 'C.A.724'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baska mask', 'description': 'In this arm the Baska mask will be used as the airway management device', 'interventionNames': ['Device: supraglottic airway placement and use']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'single use laryngeal mask airway device (LMA)', 'description': 'in this arm a single use LMA device will be used for airway management.', 'interventionNames': ['Device: supraglottic airway placement and use']}], 'interventions': [{'name': 'supraglottic airway placement and use', 'type': 'DEVICE', 'armGroupLabels': ['Baska mask', 'single use laryngeal mask airway device (LMA)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospitals', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}], 'overallOfficials': [{'name': 'Patrick Neligan, FFARCSI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Galway University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Laffey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Anaesthesia and Critical Care, Consultant Anaesthetist', 'investigatorFullName': 'John Laffey', 'investigatorAffiliation': 'University College Hospital Galway'}}}}