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

December 17, 2012
March 15, 2013
November 2012
January 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01753635 on ClinicalTrials.gov Archive Site
  • 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

Same as current
Not Provided
Not Provided
 
Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Performance and Safety of an Airway Management Device
Device: supraglottic airway placement and use
  • Experimental: Baska mask
    In this arm the Baska mask will be used as the airway management device
    Intervention: 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.
    Intervention: Device: supraglottic airway placement and use
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Female
16 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT01753635
C.A.724
No
John Laffey, University College Hospital Galway
John Laffey
Not Provided
Principal Investigator: Patrick Neligan, FFARCSI Galway University Hospitals
University College Hospital Galway
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP