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

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

Study Overview

• Status: Completed
• Conditions: Determination of the Best Predictor for Correct Baska Mask Size
• Intervention / Treatment: Device: Placement and use of Baska mask

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)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Galway University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baska	Device: Placement and use of Baska mask; use of Baska mask as component of standard general anaesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	the time from the moment the device is touched until successful ventilation is achieved or device is removed.	within 30 min of anaesthesia commencement
ease of insertion of device	we will use 10cm visual analogue scale	within 30 min of anaesthesia commencement
complications	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)	from the moment anaesthesia commenced up to the first postoperative day, an expected average of 30 hours.
Patient comfort	We will record throat pain, dysphonia and dysphagia using 10 point verbal rating scale.	from the moment patient awake up to third postoperative day, an expected average of 80 hours.

Collaborators and Investigators

• Sponsor: University College Hospital Galway
• Investigators: Principal Investigator: John G Laffey, FFARCSI, National University of Ireland, Galway, and Galway University Hospitals

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Estimate): December 25, 2012
• Last Update Submitted That Met QC Criteria: December 22, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: airway management; mask size; Baska mask; supraglottic airway
• Other Study ID Numbers: C.A.653