A Phase 2 interventional study of Placement and use of Baska mask in Performance and Safety of a New Supraglottic Airway Device, sponsored by University College Hospital Galway. Completed at 1 site in Ireland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-26.
Sponsored by University College Hospital Galway · Phase 2, Interventional, and Treatment
The Baska mask is a new supraglottic airway device . The investigators would like to assess its performance in setting in which the current standard - LMA device - is being used.
Our group has performed a number of studies on novel airway devices. In this study we would like to evaluate a new supraglottic airway named Baska mask. We would like to monitor certain parameters (time to and ease of insertion, failure rate, seal pressures, complications etc) as regarding the performance and safety profile of this device. This is a descriptive case series of patients undergoing airway management under general anaesthesia.
University College Hospital Galway is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Placement and use of Baska mask
use of a supraglottic airway device as a standard part of a general anaesthetic
Also known as: Baska mask
Device Placement Success rate
Time frame: within 30 mins of anaesthesia commencement
time to placement of device
from the moment the device touched until successful ventilation achieved or device removed
Time frame: within 30 mins of anaesthesia commencement
airway leak pressure of the device
Time frame: within 30 mins of anaesthetic commencement
user-rated ease of insertion of device
10cm visual analog score to be used
Time frame: within 30 mins of anaestesia commencement
complication rates
complications specifically monitored will be desaturation episodes, laryngospasm, blood staining of the device, lip damage. We will record other complications related to the use of the device, including but not limited to loss of airway with need to manioulate mask/switch to alternative device, regurgitation, aspiration, teeth damage.
Time frame: From the moment general anaesthesia commenced up to 1 day postoperatively
patient comfort indices
Throat pain, dysphagia and dysphonia will be assessed. 10 point verbal rating scale will be used
Time frame: from the moment the patient awake up to 1 day postoperatively
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University College Hospital Galway