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OpenTrials
Completed

NCT Number: NCT01625078

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

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

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Key information

Conditions

Baska Mask Efficacy and Safety in Children

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Galway University Hospitals

Galway, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placement and use of Baska mask

Device

Use of Baska mask as a supraglottic airway during general anesthesia

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

John Laffey

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2012
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.