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

Phase 2

Completed

• Conditions: Baska Mask Efficacy and Safety in Children
• Interventions: Device: Placement and use of Baska mask

• Registration Number: NCT01625078
• Lead Sponsor: John Laffey

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-21
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baska mask	Placement and use of Baska mask	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Galway University Hospitals; 🇮🇪 Galway, Ireland