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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Laffey, University College Hospital Galway
ClinicalTrials.gov Identifier:
NCT01625052
First received: March 23, 2012
Last updated: December 22, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Determination of the Best Predictor for Correct Baska Mask Size
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: Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients

Further study details as provided by University College Hospital Galway:

Primary Outcome Measures:
  • Determination of the best predictor for successful Baska mask size [ Time Frame: From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • insertion success rate of the device [ Time Frame: within 30 min of anaesthesia commencement ] [ Designated as safety issue: No ]
  • device airway leak pressure [ Time Frame: within 30 min of anaesthesia commencement ] [ Designated as safety issue: No ]
  • device insertion time [ Time Frame: within 30 min of anaesthesia commencement ] [ Designated as safety issue: No ]
    the time from the moment the device is touched until successful ventilation is achieved or device is removed.

  • ease of insertion of device [ Time Frame: within 30 min of anaesthesia commencement ] [ Designated as safety issue: No ]
    we will use 10cm visual analogue scale

  • complications [ Time Frame: from the moment anaesthesia commenced up to the first postoperative day, an expected average of 30 hours. ] [ Designated as safety issue: Yes ]
    Complications during insertion, maintenance and removal and in the postoperative period (in PACU and next day follow up) List of complications (not exhaustive): desaturation episodes, loss of airway with need to manipulate mask/switch to alternative device, lip/teeth damage, regurgitation, aspiration, laryngospasm, blood staining on mask removal)

  • Patient comfort [ Time Frame: from the moment patient awake up to third postoperative day, an expected average of 80 hours. ] [ Designated as safety issue: Yes ]
    We will record throat pain, dysphonia and dysphagia using 10 point verbal rating scale.


Estimated Enrollment: 50
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baska Device: Placement and use of Baska mask
use of Baska mask as component of standard general anaesthetic

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)

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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: NCT01625052

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: NCT01625052     History of Changes
Other Study ID Numbers: C.A.653
Study First Received: March 23, 2012
Last Updated: December 22, 2012
Health Authority: Ireland: Research Ethics Committee

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

ClinicalTrials.gov processed this record on August 28, 2014