Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients
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|ClinicalTrials.gov Identifier: NCT01625052|
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : December 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Determination of the Best Predictor for Correct Baska Mask Size||Device: Placement and use of Baska mask||Phase 2|
Our observational study of the performance of the Baska mask suggests that this novel supraglottic airway has promise as an alternative to the current standard device, the laryngeal mask airway (LMA). Our results indicate that while the manufacturer weight criteria work reasonably well in females this may not be the case in males. The investigators wish to determine how well the manufacturer recommended sizing criteria for the Baska mask work in males.
This study is designed to determine which criteria best predict the correct size Baska mask to use in male patients. In addition the investigators will monitor the performance and safety of this device (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Device: Placement and use of Baska mask
use of Baska mask as component of standard general anaesthetic
- Determination of the best predictor for successful Baska mask size [ Time Frame: From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours. ]We will evaluate the correlation between certain patient characteristics (including, but not limited, to actual and ideal body weight; height) and the size of the Baska mask used successfully in each patient.
- insertion success rate of the device [ Time Frame: within 30 min of anaesthesia commencement ]
- device airway leak pressure [ Time Frame: within 30 min of anaesthesia commencement ]
- device insertion time [ Time Frame: within 30 min of anaesthesia commencement ]the time from the moment the device is touched until successful ventilation is achieved or device is removed.
- ease of insertion of device [ Time Frame: within 30 min of anaesthesia commencement ]we will use 10cm visual analogue scale
- complications [ Time Frame: from the moment anaesthesia commenced up to the first postoperative day, an expected average of 30 hours. ]Complications during insertion, maintenance and removal and in the postoperative period (in PACU and next day follow up) List of complications (not exhaustive): desaturation episodes, loss of airway with need to manipulate mask/switch to alternative device, lip/teeth damage, regurgitation, aspiration, laryngospasm, blood staining on mask removal)
- Patient comfort [ Time Frame: from the moment patient awake up to third postoperative day, an expected average of 80 hours. ]We will record throat pain, dysphonia and dysphagia using 10 point verbal rating scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625052
|Galway University Hospitals|
|Principal Investigator:||John G Laffey, FFARCSI||National University of Ireland, Galway, and Galway University Hospitals|