Determination of the Best Predictor for Correct Baska Mask Size Clinical Trial
Official title:
Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients
| Verified date | December 2012 |
| Source | University College Hospital Galway |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Ireland: Research Ethics Committee |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 16 Years to 85 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Ireland | Galway University Hospitals | Galway |
| Lead Sponsor | Collaborator |
|---|---|
| University College Hospital Galway |
Ireland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determination of the best predictor for successful Baska mask size | 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. | From the moment of preoperative assessment until the moment of mask placement, an expected average of 3 hours. | No |
| Secondary | insertion success rate of the device | within 30 min of anaesthesia commencement | No | |
| Secondary | device airway leak pressure | within 30 min of anaesthesia commencement | No | |
| Secondary | device insertion time | the time from the moment the device is touched until successful ventilation is achieved or device is removed. | within 30 min of anaesthesia commencement | No |
| Secondary | ease of insertion of device | we will use 10cm visual analogue scale | within 30 min of anaesthesia commencement | No |
| Secondary | complications | 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) | from the moment anaesthesia commenced up to the first postoperative day, an expected average of 30 hours. | Yes |
| Secondary | Patient comfort | We will record throat pain, dysphonia and dysphagia using 10 point verbal rating scale. | from the moment patient awake up to third postoperative day, an expected average of 80 hours. | Yes |