Clinical trial NCT01031940: CMAC® Versus Airtraq® and Macintosh Laryngoscope in Difficult Tracheal Intubation.
Official title: Comparison of the CMAC® Device to the Airtraq® and the Macintosh Laryngoscope in Patients With Anatomical Characteristics Predictive of Difficult Tracheal Intubation.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Airway
Difficult Intubation
Airway Device
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of successful placement of Tube in the Trachea
timeFrame: immediately
Secondary outcomes:
measure: 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
timeFrame: immediately
measure: 2. Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt
timeFrame: immediately
measure: 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.
timeFrame: immediately
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospital
Study officials:
References: