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

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ClinicalTrials.gov Identifier: NCT01625078
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
John Laffey, University College Hospital Galway

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Observational Study of Baska Mask, a New Supraglottic Airway Device in Children
Study Start Date : March 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: Baska mask Device: Placement and use of Baska mask
Use of Baska mask as a supraglottic airway during general anesthesia




Primary Outcome Measures :
  1. Device insertion success rate [ Time Frame: within 30 minutes of induction of general anesthesia ]
  2. 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 Outcome Measures :
  1. airway stability [ Time Frame: within 30 minutes of device placement ]
    the tidal volumes will be measured in different head positions and the leak fractions calculated.

  2. ease of device placement [ Time Frame: within 30 minutes of induction of general anesthesia ]
    the ease of device placement will be evaluated by Visual Analogue Scale

  3. complications during the anesthetic [ Time Frame: 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



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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625078


Locations
Ireland
Galway University Hospitals
Galway, Ireland
Sponsors and Collaborators
John Laffey
Investigators
Principal Investigator: Michael Scully, FFARCSI UCHG

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
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

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