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Clinical Trials/NCT01625078
NCT01625078CompletedPhase 2

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

John Laffey1 site in 1 country20 target enrollmentStarted: March 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Device insertion success rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Experimental

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

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

John Laffey

Professor of Anaesthesia and Critical Care

University College Hospital Galway

Study Sites (1)

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