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

John Laffey

Status and phase: Completed; Phase 2

Conditions: Baska Mask Efficacy and Safety in Children

Treatments: Device: Placement and use of Baska mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01625078

C.A.657

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Baska mask

Experimental group

Treatment:

Device: Placement and use of Baska mask