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

University College Hospital Galway

Status and phase: Completed; Phase 2

Conditions: Determination of the Best Predictor for Correct Baska Mask Size

Treatments: Device: Placement and use of Baska mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01625052

C.A.653

Details and patient eligibility

About

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

Full description

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)

Enrollment: 50 estimated patients

Sex: Male

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Baska

Experimental group

Treatment:

Device: Placement and use of Baska mask