Observational Study of Baska Mask, a New Supraglottic Airway Device

NCT ID: NCT01496859

Last Updated: 2012-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Performance and Safety of a New Supraglottic Airway Device

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Baska

Group Type EXPERIMENTAL

Placement and use of Baska mask

Intervention Type DEVICE

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

Interventions

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Placement and use of Baska mask

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

Intervention Type DEVICE

Other Intervention Names

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Baska mask

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Hospital Galway

OTHER

Sponsor Role lead

Responsible Party

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John Laffey

Professor of Anaesthesia and Critical Care, Consultant Anaesthetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John G Laffey, FFARCSI

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway and Galway University Hospitals

Locations

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Galway University Hospitals

Galway, Galway, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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C.A.621

Identifier Type: -

Identifier Source: org_study_id

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