Observational Study of Baska Mask, a New Supraglottic Airway Device in Children

The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.

Study Overview

• Status: Completed
• Conditions: Baska Mask Efficacy and Safety in Children
• Intervention / Treatment: Device: Placement and use of Baska mask

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Galway University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• consent
• BMI 15-35
• weight over 30kg or age 8-16 yrs
• non-urgent surgery of planned duration up to 2 hrs

Exclusion Criteria:

• neck pathology
• previous or anticipated problems with the upper GI or upper airway
• increased risk of gastric aspiration
• expected difficult airway

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 mask	Device: Placement and use of Baska mask; Use of Baska mask as a supraglottic airway during general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device insertion success rate		within 30 minutes of induction of general anesthesia
device airway leak pressure	the airway l;eak pressure is defined as the plateau airway pressure measured while the patient is apnoeic with the APL valve of the anaesthetic machine set to 35 cm H2O and the fresh gas flow set to 6 L/min	within 10 minutes of successful device placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
airway stability	the tidal volumes will be measured in different head positions and the leak fractions calculated.	within 30 minutes of device placement
ease of device placement	the ease of device placement will be evaluated by Visual Analogue Scale	within 30 minutes of induction of general anesthesia
complications during the anesthetic	complications that may be related to the device use will be monitored including but not limited to desaturation episodes, laryngospasm, loss of airway, need to switch ot alternative device, blood staining on mask removal sore throat, dysphonia, dysphagia	from the start of device insertion untill discharge from recovery, an expected average of 2 hours

Collaborators and Investigators

• Sponsor: John Laffey
• Investigators: Principal Investigator: Michael Scully, FFARCSI, UCHG

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Estimate): May 29, 2014
• Last Update Submitted That Met QC Criteria: May 28, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Children; Pediatric; Supraglottic airway device; Baska Mask
• Other Study ID Numbers: C.A.657