Observational Study of Baska Mask, a New Supraglottic Airway Device

Phase 2

Completed

• Conditions: Performance and Safety of a New Supraglottic Airway Device
• Interventions: Device: Placement and use of Baska mask

• Registration Number: NCT01496859
• Lead Sponsor: University College Hospital Galway

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-18
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-23
• Last Update Posted: 2012-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baska	Placement and use of Baska mask	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
user-rated ease of insertion of device	within 30 mins of anaestesia commencement	10cm visual analog score to be used
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	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

Trial Locations

Locations (1)

Galway University Hospitals; 🇮🇪 Galway, Ireland