Observational Study of Baska Mask, a New Supraglottic Airway Device in Children

NCT ID: NCT01625078

Last Updated: 2014-05-29

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-06-30

Brief Summary

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The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.

Detailed Description

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Conditions

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Baska Mask Efficacy and Safety in Children

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 mask

Group Type EXPERIMENTAL

Placement and use of Baska mask

Intervention Type DEVICE

Use of Baska mask as a supraglottic airway during general anesthesia

Interventions

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Placement and use of Baska mask

Use of Baska mask as a supraglottic airway during general anesthesia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* consent
* BMI 15-35
* weight over 30kg or age 8-16 yrs
* non-urgent surgery of planned duration up to 2 hrs

Exclusion Criteria

* neck pathology
* previous or anticipated problems with the upper GI or upper airway
* increased risk of gastric aspiration
* expected difficult airway
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John Laffey

OTHER

Sponsor Role lead

Responsible Party

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John Laffey

Professor of Anaesthesia and Critical Care

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael Scully, FFARCSI

Role: PRINCIPAL_INVESTIGATOR

UCHG

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.657

Identifier Type: -

Identifier Source: org_study_id

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