Status:
COMPLETED
Comparison of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients
Lead Sponsor:
University College Hospital Galway
Conditions:
Performance and Safety of an Airway Management Device
Eligibility:
FEMALE
16-85 years
Phase:
PHASE2
Brief Summary
The investigators have 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 proposed st...
Detailed Description
Airway management is essential component of the safe and efficient provision of general anaesthesia. Supraglottic airway devices have established place in the airway management. The Baska mask is a n...
Eligibility Criteria
Inclusion
- Female
- 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
- 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
- Live Pregnancy
- Increased risk for Gastric Aspiration
- Current participation in another Clinical Study
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01482650
Start Date
November 1 2011
End Date
February 1 2012
Last Update
June 19 2012
Active Locations (1)
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1
Galway University Hospitals
Galway, Galway, Ireland