Observational Study of Baska Mask, a New Supraglottic Airway Device

Performance and Safety of a New Supraglottic Airway Device Clinical Trial

Official title:

Observational Study of Baska Mask, a New Supraglottic Airway Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496859
• Other study ID #: C.A.621
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2011
• Last updated: March 23, 2012
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Written informed Consent

• No relevant drug allergies

• Body-mass index (BMI) 20-35

• Age 18-65

• Non-urgent surgery of planned duration 0-2 hrs

Exclusion Criteria:

• Inability of patient/parent to understand or consent for the trial

• Non-English speakers

• 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 etc)

• BMI >35

• Expected Difficult airway

• Live Pregnancy

• Increased risk for Gastric Aspiration

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Performance and Safety of a New Supraglottic Airway Device

Intervention

Device:
• Placement and use of Baska mask
use of a supraglottic airway device as a standard part of a general anaesthetic

Locations

Country	Name	City	State
Ireland	Galway University Hospitals	Galway

Sponsors (1)

Lead Sponsor	Collaborator
University College Hospital Galway

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Placement Success rate		within 30 mins of anaesthesia commencement	No
Primary	time to placement of device	from the moment the device touched until successful ventilation achieved or device removed	within 30 mins of anaesthesia commencement	No
Secondary	airway leak pressure of the device		within 30 mins of anaesthetic commencement	No
Secondary	user-rated ease of insertion of device	10cm visual analog score to be used	within 30 mins of anaestesia commencement	No
Secondary	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.	From the moment general anaesthesia commenced up to 1 day postoperatively	Yes
Secondary	patient comfort indices	Throat pain, dysphagia and dysphonia will be assessed. 10 point verbal rating scale will be used	from the moment the patient awake up to 1 day postoperatively	Yes