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

NCT ID: NCT01625052

Last Updated: 2012-12-25

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-06-30

Brief Summary

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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

Detailed Description

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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)

Conditions

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Determination of the Best Predictor for Correct Baska Mask Size

Keywords

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mask size Baska mask supraglottic airway airway management

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 Baska mask as component of standard general anaesthetic

Interventions

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Placement and use of Baska mask

use of Baska mask as component of standard general anaesthetic

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

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.653

Identifier Type: -

Identifier Source: org_study_id