Baska Mask Efficacy and Safety in Children Clinical Trial
Official title:
Observational Study of Baska Mask, a New Supraglottic Airway Device in Children
| Verified date | May 2014 |
| Source | University College Hospital Galway |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Ireland: Research Ethics Committee |
| Study type | Interventional |
The investigators wish to accumulate initial data on the performance and safety of the Baska mask in paediatric patient population.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 8 Years to 16 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Galway University Hospitals | Galway |
| Lead Sponsor | Collaborator |
|---|---|
| John Laffey |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Device insertion success rate | within 30 minutes of induction of general anesthesia | No | |
| Primary | 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 | No |
| Secondary | airway stability | the tidal volumes will be measured in different head positions and the leak fractions calculated. | within 30 minutes of device placement | No |
| Secondary | ease of device placement | the ease of device placement will be evaluated by Visual Analogue Scale | within 30 minutes of induction of general anesthesia | No |
| Secondary | 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 | Yes |