Observational Study of Baska Mask, a New Supraglottic Airway Device

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.

Study Overview

• Status: Completed
• Conditions: Performance and Safety of a New Supraglottic Airway Device
• Intervention / Treatment: Device: Placement and use of Baska mask

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Galway University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baska	Device: Placement and use of Baska mask; use of a supraglottic airway device as a standard part of a general anaesthetic; Other Names: Baska mask

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College Hospital Galway
• Investigators: Principal Investigator: John G Laffey, FFARCSI, National University of Ireland, Galway and Galway University Hospitals

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 18, 2011
• First Submitted That Met QC Criteria: December 20, 2011
• First Posted (Estimate): December 21, 2011

Study Record Updates

• Last Update Posted (Estimate): March 26, 2012
• Last Update Submitted That Met QC Criteria: March 23, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: airway management; Baska mask; supraglottic airway
• Other Study ID Numbers: C.A.621