Observational Study of Baska Mask, a New Supraglottic Air... | NCT01496859

Studies
Observational Study of Baska Mask, a New Supraglottic Airway Device

NCT01496859

Sponsor

University College Hospital Galway

Status

Completed

Last Update Posted

Mar 26, 2012Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

Performance and Safety of a New Supraglottic Airway Device

Interventions

Placement and use of Baska mask

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 18, 2011

First Submission Date that Met QC Criteria

Dec 20, 2011

First Posted Date

Dec 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2012

Last Update Posted Date

Mar 26, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Laffey, Professor of Anaesthesia and Critical Care, Consultant Anaesthetist, University College Hospital GalwayPrincipal Investigator

Lead Sponsor

University College Hospital GalwayOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Baska	Experimental		Device: Placement and use of Baska mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placement and use of Baska mask	Device	use of a supraglottic airway device as a standard part of a general anaesthetic	Baska

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John G Laffey, FFARCSI	National University of Ireland, Galway and Galway University Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Galway University Hospitals		Galway	Galway		Ireland

Intervention Browse Module

MeSH Terms

ID	Term
D016254	Mutagenesis, Insertional

Ancestor Terms

ID	Term
D015202	Protein Engineering
D005818	Genetic Engineering
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided