Observational Study of Baska Mask, a New Supraglottic Airway Device

University College Hospital Galway30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Performance and Safety of a New Supraglottic Airway Device

Interventions

Placement and use of Baska maskDEVICE

use of a supraglottic airway device as a standard part of a general anaesthetic

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Galway University Hospitals

Galway, Galway, Ireland

Outcomes

Primary Outcomes

Device Placement Success rate

Time frame: within 30 mins of anaesthesia commencement

time to placement of device

from the moment the device touched until successful ventilation achieved or device removed

Time frame: within 30 mins of anaesthesia commencement

Secondary Outcomes

airway leak pressure of the device

Time frame: within 30 mins of anaesthetic commencement

user-rated ease of insertion of device

10cm visual analog score to be used

Time frame: 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.

Time frame: 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

Time frame: from the moment the patient awake up to 1 day postoperatively

Data from ClinicalTrials.gov

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