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.

Study Overview

• Status: Completed
• Conditions: Performance and Safety of an Airway Management Device
• Intervention / Treatment: Device: supraglottic airway placement and use

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Galway University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Written informed consent
• ASA 1-3
• No relevant allergies
• Body-mass index (BMI) 35 or less
• Age 16-85
• Non-urgent surgery of planned duration under 4 hours

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
• BMI >35
• Predicted or previously documented difficult airway
• Live Pregnancy
• Increased risk for Gastric Aspiration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baska mask; In this arm the Baska mask will be used as the airway management device	Device: supraglottic airway placement and use
Active Comparator: single use laryngeal mask airway device (LMA); in this arm a single use LMA device will be used for airway management.	Device: supraglottic airway placement and use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful placement of the supraglottic device on first attempt	The hypothesis is that the Baska mask will have first time placement attempt success rate that is no more than 15% less than that of the comparator - a single use LMA device.	within 30 minutes of commencement of general anesthesia
Seal pressure of the supraglottic device	The investigators will measure the airway seal provided by the device used. The hypothesis is that the seal pressure of the Baska mask is 20% higher than that of the comparator single-use LMA device.	Within 30 minutes of commencement of general anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall rate of successful placement of the supraglottic device		Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed.
Number of device placement attempts		Within 30 minutes of commencement of general anesthesia
Number of optimization maneuvers during device placement		Within 30 minutes of commencement of general anesthesia
user rated Device difficulty score	the investigators will use 10 cm visual analogue scale to score the whole experience of using the device until successful ventilation is achieved.	within 30 minutes of commencement of general anesthesia
vitals parameter stability	The investigators will record non-invasive arterial oxygen saturation, heart rate and blood pressure preoperatively, after induction of general anesthesia and after placement of the airway device.	in the period immediately before and within the first 35 minutes of general anesthesia
Laryngeal view obtained on fiberoptic assessment	The investigators will perform this when feasible.	within 2 hours of commencement of general anesthesia
Complication rates	Complications specifically monitored will be: blood staining, laryngospasm, lip damage, throat pain, dysphagia, dysphonia, heartburn, nausea and vomiting. The investigators will record other complications related to the use of the device, including but not limited to: desaturation, need to reposition device or switch to alternative device, teeth damage, regurgitation, aspiration	from the moment general anesthesia commenced up to 3 days postoperatively

Collaborators and Investigators

• Sponsor: John Laffey
• Investigators: Principal Investigator: Patrick Neligan, FFARCSI, Galway University Hospitals

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): March 19, 2013
• Last Update Submitted That Met QC Criteria: March 15, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: laryngeal mask airway; supraglottic airway device; Baska mask; LMA; single use LMA device
• Other Study ID Numbers: C.A.724