Observational Study of Baska Mask, a New Supraglottic Airway Device in Children
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- John Laffey
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Device insertion success rate
Study Overview
Brief Summary
The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Baska mask
Intervention: Placement and use of Baska mask (Device)
Outcomes
Primary Outcomes
Device insertion success rate
Time Frame: within 30 minutes of induction of general anesthesia
device airway leak pressure
Time Frame: within 10 minutes of successful device placement
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
Secondary Outcomes
- airway stability(within 30 minutes of device placement)
- ease of device placement(within 30 minutes of induction of general anesthesia)
- complications during the anesthetic(from the start of device insertion untill discharge from recovery, an expected average of 2 hours)
Investigators
John Laffey
Professor of Anaesthesia and Critical Care
University College Hospital Galway
