Observational Study of Baska Mask, a New Supraglottic Airway Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Laffey, University College Hospital Galway
ClinicalTrials.gov Identifier:
NCT01496859
First received: December 18, 2011
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Performance and Safety of a New Supraglottic Airway Device
Device: Placement and use of Baska mask
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Observational Study of Baska Mask, a New Supraglottic Airway Device

Further study details as provided by University College Hospital Galway:

Primary Outcome Measures:
  • Device Placement Success rate [ Time Frame: within 30 mins of anaesthesia commencement ] [ Designated as safety issue: No ]
  • time to placement of device [ Time Frame: within 30 mins of anaesthesia commencement ] [ Designated as safety issue: No ]
    from the moment the device touched until successful ventilation achieved or device removed


Secondary Outcome Measures:
  • airway leak pressure of the device [ Time Frame: within 30 mins of anaesthetic commencement ] [ Designated as safety issue: No ]
  • user-rated ease of insertion of device [ Time Frame: within 30 mins of anaestesia commencement ] [ Designated as safety issue: No ]
    10cm visual analog score to be used

  • complication rates [ Time Frame: From the moment general anaesthesia commenced up to 1 day postoperatively ] [ Designated as safety issue: Yes ]
    complications specifically monitored will be desaturation episodes, laryngospasm, blood staining of the device, lip damage. We will record other complications related to the use of the device, including but not limited to loss of airway with need to manioulate mask/switch to alternative device, regurgitation, aspiration, teeth damage.

  • patient comfort indices [ Time Frame: from the moment the patient awake up to 1 day postoperatively ] [ Designated as safety issue: Yes ]
    Throat pain, dysphagia and dysphonia will be assessed. 10 point verbal rating scale will be used


Enrollment: 30
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baska Device: Placement and use of Baska mask
use of a supraglottic airway device as a standard part of a general anaesthetic
Other Name: Baska mask

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496859

Locations
Ireland
Galway University Hospitals
Galway, Ireland
Sponsors and Collaborators
University College Hospital Galway
Investigators
Principal Investigator: John G Laffey, FFARCSI National University of Ireland, Galway and Galway University Hospitals
  More Information

No publications provided

Responsible Party: John Laffey, Professor of Anaesthesia and Critical Care, Consultant Anaesthetist, University College Hospital Galway
ClinicalTrials.gov Identifier: NCT01496859     History of Changes
Other Study ID Numbers: C.A.621
Study First Received: December 18, 2011
Last Updated: March 23, 2012
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Hospital Galway:
Baska mask
supraglottic airway
airway management

ClinicalTrials.gov processed this record on August 28, 2014