CMAC® Versus Airtraq® and Macintosh Laryngoscope in Difficult Tracheal Intubation.
|ClinicalTrials.gov Identifier: NCT01031940|
Recruitment Status : Terminated (Insufficient Recruitment. Findings of concurrent study in low risk population not supportive of hypotheses in this study.)
First Posted : December 15, 2009
Last Update Posted : June 19, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Airway Difficult Intubation Airway Device||Device: macintosh laryngoscope Device: C-MAC laryngoscope Device: Airtraq device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
|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
- Rate of successful placement of Tube in the Trachea [ Time Frame: immediately ]
- 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 [ Time Frame: immediately ]
- 2. Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt [ Time Frame: 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. [ Time Frame: immediately ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031940
|Galway University Hospital|