Performance and Safety of a New Supraglottic Airway Device
Conditions
Keywords
Baska mask, supraglottic airway, airway management
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.
Interventions
use of a supraglottic airway device as a standard part of a general anaesthetic
Sponsors
University College Hospital Galway
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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) * BMI \>35 * Expected Difficult airway * Live Pregnancy * Increased risk for Gastric Aspiration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Placement Success rate | within 30 mins of anaesthesia commencement | — |
| time to placement of device | within 30 mins of anaesthesia commencement | from the moment the device touched until successful ventilation achieved or device removed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| airway leak pressure of the device | within 30 mins of anaesthetic commencement | — |
| user-rated ease of insertion of device | within 30 mins of anaestesia commencement | 10cm visual analog score to be used |
| complication rates | From the moment general anaesthesia commenced up to 1 day postoperatively | 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. |
| patient comfort indices | from the moment the patient awake up to 1 day postoperatively | Throat pain, dysphagia and dysphonia will be assessed. 10 point verbal rating scale will be used |
Countries
Ireland
Outcome results
None listed