Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients

Study Overview
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Brief Summary
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The investigators group has performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask. In this new study the investigators wish to determine which criteria best predict the correct size of the Baska mask to be used in male patients

Detailed Description
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Our observational study of the performance of the Baska mask suggests that this novel supraglottic airway has promise as an alternative to the current standard device, the laryngeal mask airway (LMA). Our results indicate that while the manufacturer weight criteria work reasonably well in females this may not be the case in males. The investigators wish to determine how well the manufacturer recommended sizing criteria for the Baska mask work in males. This study is designed to determine which criteria best predict the correct size Baska mask to use in male patients. In addition the investigators will monitor the performance and safety of this device (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc)

Official Title
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Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients

Conditions
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Determination of the Best Predictor for Correct Baska Mask Size

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: Male Written informed consent ASA 1-3 No relevant allergies Body-mass index (BMI) 20-35 Age 16-85 Non-urgent surgery of planned duration 0.25-4 hrs Exclusion Criteria: Inability of patient/parent to understand or consent for the trial 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) BMI > 35 Predicted or previously documented difficult airway Increased risk for Gastric Aspiration Current participation in another Clinical Study

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

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 Baska mask as component of standard general anaesthetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the best predictor for successful Baska mask size | We will evaluate the correlation between certain patient characteristics (including, but not limited, to actual and ideal body weight; height) and the size of the Baska mask used successfully in each patient. | From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion success rate of the device |  | within 30 min of anaesthesia commencement | 
| device airway leak pressure |  | within 30 min of anaesthesia commencement | 
| device insertion time | the time from the moment the device is touched until successful ventilation is achieved or device is removed. | within 30 min of anaesthesia commencement | 
| ease of insertion of device | we will use 10cm visual analogue scale | within 30 min of anaesthesia commencement | 
| complications | Complications during insertion, maintenance and removal and in the postoperative period (in PACU and next day follow up) List of complications (not exhaustive): desaturation episodes, loss of airway with need to manipulate mask/switch to alternative device, lip/teeth damage, regurgitation, aspiration, laryngospasm, blood staining on mask removal) | from the moment anaesthesia commenced up to the first postoperative day, an expected average of 30 hours. | 
| Patient comfort | We will record throat pain, dysphonia and dysphagia using 10 point verbal rating scale. | from the moment patient awake up to third postoperative day, an expected average of 80 hours. | 

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