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

Difficult Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01031940
• Other study ID #: CMAC-1
• Status: Terminated
• Phase: N/A
• First received: December 14, 2009
• Last updated: June 17, 2012
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2012
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway
• Airway Device
• Difficult Intubation

Intervention

Device:
• macintosh laryngoscope
intubate with the macintosh laryngoscope
• C-MAC laryngoscope
intubate with the C-MAC laryngoscope
• Airtraq device
intubate with the Airtraq device

Locations

Country	Name	City	State
Ireland	Galway University Hospital	Galway

Sponsors (1)

Lead Sponsor	Collaborator
University College Hospital Galway

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful placement of Tube in the Trachea		immediately	Yes
Secondary	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	Yes
Secondary	2. Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt		immediately	Yes
Secondary	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	Yes