Baska Mask Efficacy and Safety in Children
Conditions
Keywords
Baska Mask, Supraglottic airway device, Children, Pediatric
Brief summary
The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.
Interventions
Use of Baska mask as a supraglottic airway during general anesthesia
Sponsors
John Laffey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device insertion success rate | within 30 minutes of induction of general anesthesia | — |
| device airway leak pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| airway stability | within 30 minutes of device placement | the tidal volumes will be measured in different head positions and the leak fractions calculated. |
| ease of device placement | within 30 minutes of induction of general anesthesia | the ease of device placement will be evaluated by Visual Analogue Scale |
| complications during the anesthetic | from the start of device insertion untill discharge from recovery, an expected average of 2 hours | 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 |
Countries
Ireland
Outcome results
None listed