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

This study is currently recruiting participants.
Verified June 2012 by University College Hospital Galway
Sponsor:
Information provided by (Responsible Party):
John Laffey, University College Hospital Galway
ClinicalTrials.gov Identifier:
NCT01625078
First received: March 23, 2012
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Baska Mask Efficacy and Safety in Children
Device: Placement and use of Baska mask
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Observational Study of Baska Mask, a New Supraglottic Airway Device in Children

Further study details as provided by University College Hospital Galway:

Primary Outcome Measures:
  • Device insertion success rate [ Time Frame: within 30 minutes of unduction of general anesthesia ] [ Designated as safety issue: No ]
  • device airway leak pressure [ Time Frame: within 10 minutes of successful device placement ] [ Designated as safety issue: No ]
    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 mashine set to 35 cm H2O and the fresh gas flow set to 6 L/min


Secondary Outcome Measures:
  • airway stability [ Time Frame: within 30 minutes of device placement ] [ Designated as safety issue: No ]
    the tidal volumes will be measured in different head positions and the leak fractions caolculated.

  • ease of device placement [ Time Frame: within 30 minutes of induction of general anesthesia ] [ Designated as safety issue: No ]
    the ease of device placement will be evaluated by Visual Analogue Scale

  • complications during the anesthetic [ Time Frame: from the start of device insertion untill discharge from recovery, an expected average of 2 hours ] [ Designated as safety issue: Yes ]
    complications that may be rerated to the device use will be monitored including but not limited to desaturation episodes, laryngospasm, loss of airway, need to switch ot alternatuve device, blood staining on mask removal sore throat, dysphonia, dysphagia


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baska mask Device: Placement and use of Baska mask
Use of Baska mask as a supraglottic airway during general anesthesia

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625078

Contacts
Contact: John G Laffey, FFARCSI +35391544074 john.laffey@nuigalway.ie
Contact: Vladimir Alexiev, FCARCSI +35391544074 vladimir.alexiev@nuigalway.ie

Locations
Ireland
Galway University Hospitals Recruiting
Galway, Ireland
Principal Investigator: John Laffey, FFARCSI         
Sub-Investigator: Vladimir Alexiev, FCARCSI         
Sponsors and Collaborators
University College Hospital Galway
Investigators
Principal Investigator: John G Laffey, FFARCSI UCHG
  More Information

No publications provided

Responsible Party: John Laffey, Professor of Anaesthesia and Critical Care, University College Hospital Galway
ClinicalTrials.gov Identifier: NCT01625078     History of Changes
Other Study ID Numbers: C.A.657
Study First Received: March 23, 2012
Last Updated: June 21, 2012
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Hospital Galway:
Baska Mask
Supraglottic airway device
Children
Pediatric

ClinicalTrials.gov processed this record on April 23, 2014