Performance and Safety of an Airway Management Device Clinical Trial
Official title:
Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients
The purpose of this study is to compare the performance of the Baska mask supraglottic
airway device with a single use laryngeal mask device (LMA) in low-risk female patients.
The investigators have performed a number of studies on novel airway devices, including 3
studies on the Baska mask. This trial will compare some performance characteristics of the
studied devices, including airway seal pressures, insertion success rates, device use
difficulty scores. Additional performance and device safety data will be accumulated.
The investigators have two primary hypotheses, namely 1.Non-inferiority of first placement
attempt success rate of the Baska mask vs LMA; and 2.greater seal pressure of the Baska mask
vs LMA.
Supraglottic airway devices have established place in the airway management in patients
undergoing general anesthesia.
The Baska mask is a new supraglottic airway device. It's features include:
1. Non pressurized cuff designed to reduce the risk of oropharyngeal tissue damage.
2. Improved cuff seal during the inspiratory phase of positive pressure ventilation
3. An improved system for drainage of oropharyngeal contents intended to reduce the rate
of lung aspiration.
4. Integrated bite-block to reduce the risk of patients biting and blocking the airway.
This study is randomized, single-blinded, controlled trial. The participants will be
allocated to two groups, in which either the Baska mask or the single use LMA will be the
primary airway management device.
Clinical Research Ethics Committee approval has been obtained. Suitable participants will be
recruited after written informed consent.
Standard anesthetic preassesment and anesthesia will be provided.
Consenting patients will be randomly allocated to either of the 2 study groups.
Protocol for airway size selection and attempts at placement will be followed.
The investigators will monitor a number of parameters, including time and ease of insertion,
airway seal pressure, airway leak, complications related to device use and other.
Follow up will be performed.
The investigators have two primary hypotheses:
1. That the Baska mask is non-inferior to LMA in respect if first placement attempt
success rate. A greater than 15% difference in success rate will be considered a
clinically important difference and will disprove this hypothesis.
2. The Baska mask is superior in respect of seal pressure. A 20% higher seal pressure with
Baska as compared to the LMA device seal pressure will be considered a clinically
important difference.
Interim analysis will be performed once 75 patients are recruited per group. This is
reasonable as this figure exceeds that required to prove or disprove the primary hypothesis
regarding the seal pressure. The study will only be stopped at this stage if the
non-inferiority hypothesis is disproven with P value < 0.01
In addition to the above the investigators will evaluate a number of secondary outcomes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01482650 -
Comparison of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients
|
Phase 2 | |
| Completed |
NCT01757977 -
A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery
|
N/A |