Determination of the Optimal Approach to Select the Best... | NCT01625052

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

NCT01625052

Sponsor

University College Hospital Galway

Status

Completed

Last Update Posted

Dec 25, 2012Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Determination of the Best Predictor for Correct Baska Mask Size

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

Dec 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

Jan 2012

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 23, 2012

First Submission Date that Met QC Criteria

Jun 20, 2012

First Posted Date

Jun 21, 2012Estimated

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

Dec 22, 2012

Last Update Posted Date

Dec 25, 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 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

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)

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

50Estimated

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 Baska mask as component of standard general anaesthetic	Baska

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of the best predictor for successful Baska mask size	We will evaluate the correlation between certain patient characteristics (including, but not limited, to actual and ideal body weight; height) and the size of the Baska mask used successfully in each patient.	From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours.

Secondary Outcomes

Measure	Description	Time Frame
insertion success rate of the device		within 30 min of anaesthesia commencement
device airway leak pressure		within 30 min of anaesthesia commencement
device insertion time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder 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

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Browse Branches

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