CMAC® Versus Airtraq® and Macintosh Laryngoscope in Difficult Tracheal Intubation.

Comparison of the CMAC® Device to the Airtraq® and the Macintosh Laryngoscope in Patients With Anatomical Characteristics Predictive of Difficult Tracheal Intubation.

It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where anatomical characteristics predictive of difficult intubation are present.

The CMAC® Laryngoscope is a new intubating device. It is designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.

The CMAC may be especially effective in situations where intubation of the trachea is potentially difficult.

The efficacy of this device in comparison to the traditional Macintosh laryngoscope and other novel laryngoscopes is not known.

We aim to compare its performance to that of the Macintosh laryngoscope, the gold standard device, in patients with one or more anatomical characteristics predictive of difficult intubation.

The investigators further aim to compare it to the Airtraq® device a device which has been shown to be superior to the Macintosh laryngoscope in previous trials.

The investigators primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the CMAC than using the Macintosh laryngoscope in patients with two or more anatomical characteristics predictive of difficult intubation.

The investigators further hypothesize that the Airtraq® will be superior the CMAC® with one or more anatomical characteristics predictive of difficult intubation.

Study Overview

• Status: Terminated
• Conditions: Difficult Intubation; Airway; Airway Device
• Intervention / Treatment: Device: macintosh laryngoscope; Device: C-MAC laryngoscope; Device: Airtraq device

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Galway University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA 1-3 patients undergoing surgical procedures requiring orotracheal intubation.
• Written informed Consent
• No relevant drug allergies

• Patients with 2 or more of the following predictors of difficult intubation:

  • Mallampatti II - IV
  • Thyromental distance < 6cm
  • Mouth opening < 3.5 cm
  • Cervical spine disease
  • Anteriorly protruding incisors
  • Presence of Caps or Crowns

Exclusion Criteria:

• Patients with history of or risk factors for gastric regurgitation
• Patients unable to consent for the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: macintosh	Device: macintosh laryngoscope; intubate with the macintosh laryngoscope
Active Comparator: C-MAC	Device: C-MAC laryngoscope; intubate with the C-MAC laryngoscope
Active Comparator: Airtraq	Device: Airtraq device; intubate with the Airtraq device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of successful placement of Tube in the Trachea	immediately

Secondary Outcome Measures

Outcome Measure	Time Frame
1. Duration of Intubation attempt (successful Attempts only) a. Absolute time taken to perform successful tracheal intubation b. Number of successful intubations completed within 30 seconds	immediately
2. Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt	immediately
3. Laryngeal View Obtained c. Cormac and Lehane Grading of Best Laryngeal View d. Change in view compared to initial assessment by independent anaesthetist. e. POGO score.	immediately

Collaborators and Investigators

• Sponsor: University College Hospital Galway

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): June 19, 2012
• Last Update Submitted That Met QC Criteria: June 17, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: CMAC-1