Observational Study of Baska Mask, a New Supraglottic Airway Device

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study of Baska Mask, a New Supraglottic Airway Device

Conditions
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Performance and Safety of a New Supraglottic Airway Device

Intervention / Treatment
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* Device: Placement and use of Baska mask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baska<br> | Device: Placement and use of Baska mask<br>* use of a supraglottic airway device as a standard part of a general anaesthetic<br>* Other names: Baska mask;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Placement Success rate |  | within 30 mins of anaesthesia commencement | 
| time to placement of device | from the moment the device touched until successful ventilation achieved or device removed | within 30 mins of anaesthesia commencement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway leak pressure of the device |  | within 30 mins of anaesthetic commencement | 
| user-rated ease of insertion of device | 10cm visual analog score to be used | within 30 mins of anaestesia commencement | 
| complication rates | 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. | From the moment general anaesthesia commenced up to 1 day postoperatively | 
| patient comfort indices | Throat pain, dysphagia and dysphonia will be assessed. 10 point verbal rating scale will be used | from the moment the patient awake up to 1 day postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Baska mask, supraglottic airway, airway management