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Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Laffey, University College Hospital Galway
ClinicalTrials.gov Identifier:
NCT01753635
First received: December 17, 2012
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Performance and Safety of an Airway Management Device
Device: supraglottic airway placement and use

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients

Further study details as provided by University College Hospital Galway:

Primary Outcome Measures:
  • Rate of successful placement of the supraglottic device on first attempt [ Time Frame: within 30 minutes of commencement of general anesthesia ] [ Designated as safety issue: No ]
    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.

  • Seal pressure of the supraglottic device [ Time Frame: Within 30 minutes of commencement of general anesthesia ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall rate of successful placement of the supraglottic device [ Time Frame: Within 30 minutes of commencement of general anesthesia. Up to 3 device placement attempts are allowed. ] [ Designated as safety issue: No ]
  • Number of device placement attempts [ Time Frame: Within 30 minutes of commencement of general anesthesia ] [ Designated as safety issue: No ]
  • Number of optimization maneuvers during device placement [ Time Frame: Within 30 minutes of commencement of general anesthesia ] [ Designated as safety issue: No ]
  • user rated Device difficulty score [ Time Frame: within 30 minutes of commencement of general anesthesia ] [ Designated as safety issue: No ]
    the investigators will use 10 cm visual analogue scale to score the whole experience of using the device until successful ventilation is achieved.

  • vitals parameter stability [ Time Frame: in the period immediately before and within the first 35 minutes of general anesthesia ] [ Designated as safety issue: No ]
    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.

  • Laryngeal view obtained on fiberoptic assessment [ Time Frame: within 2 hours of commencement of general anesthesia ] [ Designated as safety issue: No ]
    The investigators will perform this when feasible.

  • Complication rates [ Time Frame: from the moment general anesthesia commenced up to 3 days postoperatively ] [ Designated as safety issue: Yes ]

    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



Enrollment: 150
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753635

Locations
Ireland
Galway University Hospitals
Galway, Ireland
Sponsors and Collaborators
John Laffey
Investigators
Principal Investigator: Patrick Neligan, FFARCSI Galway University Hospitals
  More Information

No publications provided

Responsible Party: John Laffey, Professor of Anaesthesia and Critical Care, Consultant Anaesthetist, University College Hospital Galway
ClinicalTrials.gov Identifier: NCT01753635     History of Changes
Other Study ID Numbers: C.A.724
Study First Received: December 17, 2012
Last Updated: March 15, 2013
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Hospital Galway:
Baska mask
LMA
single use LMA device
laryngeal mask airway
supraglottic airway device

ClinicalTrials.gov processed this record on November 25, 2014