Completed

NCT Number: NCT01625052

Determination of the Optimal Approach to Select the Best Size of BASKA Mask to Use in Male Patients

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

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Key information

Conditions

Determination of the Best Predictor for Correct Baska Mask Size

Age range

16 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Galway University Hospitals

Galway, Ireland

About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Placement and use of Baska mask

Device

use of Baska mask as component of standard general anaesthetic

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

University College Hospital Galway

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jun 21, 2012
Registry last updated: Dec 25, 2012

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.