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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.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01031940
Enrollment
15
Registered
2009-12-15
Start date
2010-01-31
Completion date
2011-03-31
Last updated
2012-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway, Airway Device, Difficult Intubation

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.

Interventions

DEVICEmacintosh laryngoscope

intubate with the macintosh laryngoscope

intubate with the C-MAC laryngoscope

DEVICEAirtraq device

intubate with the Airtraq device

Sponsors

University College Hospital Galway
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of successful placement of Tube in the Tracheaimmediately

Secondary

MeasureTime 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 secondsimmediately
2. Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attemptimmediately
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

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026