Observational Study of Baska Mask, a New Supraglottic Airway Device
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Performance and Safety of a New Supraglottic Airway Device
- Sponsor
- University College Hospital Galway
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Device Placement Success rate
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
John Laffey
Professor of Anaesthesia and Critical Care, Consultant Anaesthetist
University College Hospital Galway
Eligibility Criteria
Inclusion Criteria
- •Written informed Consent
- •No relevant drug allergies
- •Body-mass index (BMI) 20-35
- •Age 18-65
- •Non-urgent surgery of planned duration 0-2 hrs
Exclusion Criteria
- •Inability of patient/parent to understand or consent for the trial
- •Non-English speakers
- •Neck pathology
- •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)
- •Expected Difficult airway
- •Live Pregnancy
- •Increased risk for Gastric Aspiration
Outcomes
Primary Outcomes
Device Placement Success rate
Time Frame: within 30 mins of anaesthesia commencement
time to placement of device
Time Frame: within 30 mins of anaesthesia commencement
from the moment the device touched until successful ventilation achieved or device removed
Secondary Outcomes
- user-rated ease of insertion of device(within 30 mins of anaestesia commencement)
- airway leak pressure of the device(within 30 mins of anaesthetic commencement)
- complication rates(From the moment general anaesthesia commenced up to 1 day postoperatively)
- patient comfort indices(from the moment the patient awake up to 1 day postoperatively)