Clinical trial NCT01625052: Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients
Official title: Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Determination of the Best Predictor for Correct Baska Mask Size
Keywords: mask size
Baska mask
supraglottic airway
airway management
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 50
Sex: MALE
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators group has performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask. In this new study the investigators wish to determine which criteria best predict the correct size of the Baska mask to be used in male patients

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* Male
* Written informed consent
* ASA 1-3
* No relevant allergies
* Body-mass index (BMI) 20-35
* Age 16-85
* Non-urgent surgery of planned duration 0.25-4 hrs

Exclusion Criteria:

* Inability of patient/parent to understand or consent for the trial
* Neck pathology
* Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days)
* BMI \> 35
* Predicted or previously documented difficult airway
* Increased risk for Gastric Aspiration
* Current participation in another Clinical Study

Primary outcomes:
measure: Determination of the best predictor for successful Baska mask size
timeFrame: From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours.
Secondary outcomes:
measure: insertion success rate of the device
timeFrame: within 30 min of anaesthesia commencement
measure: device airway leak pressure
timeFrame: within 30 min of anaesthesia commencement
measure: device insertion time
timeFrame: within 30 min of anaesthesia commencement
measure: ease of insertion of device
timeFrame: within 30 min of anaesthesia commencement
measure: complications
timeFrame: from the moment anaesthesia commenced up to the first postoperative day, an expected average of 30 hours.
measure: Patient comfort
timeFrame: from the moment patient awake up to third postoperative day, an expected average of 80 hours.
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospitals
Study officials:
affiliation: National University of Ireland, Galway, and Galway University Hospitals
name: John G Laffey, FFARCSI
role: PRINCIPAL_INVESTIGATOR
References: