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Comparison of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients

NCT01482650 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2012-06-19

No results posted yet for this study

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 study the investigators would like to compare directly,in a randomized clinical trial, this device with the device the investigators routinely use - the single use laryngeal mask airway - LMA, in female patients undergoing general anaesthesia.

This study will determine which device performs best, as measured by key parameters (insertion success rate, seal pressures, time to and ease of insertion, failure rate, complications etc) as regarding the performance and safety profile of the Baska mask and the LMA.

The investigators have two study hypotheses, namely (1) non-inferiority of first placement attempt success rate of Baska vs LMA; and (2) greater seal pressure of the Baska mask vs LMA.

A number of secondary endpoints will be monitored and analyzed (time to and ease of insertion, failure rate, complications etc).

Conditions

  • Performance and Safety of an Airway Management Device

Interventions

DEVICE

supraglottic airway placement and use

The investigators will place the device (Baska mask or LMA) according to a pre-defined protocol and monitor its performance intra and postoperatively.

Sponsors & Collaborators

  • University College Hospital Galway

    lead OTHER

Principal Investigators

  • John Laffey, FFARCSI · National University of Ireland, Galway, and Galway University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01482650 on ClinicalTrials.gov