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

NCT01031940 | Terminated

• 1 other identifier: CMAC-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway; Difficult Intubation; Airway Device

Outcome Measures

Primary Outcomes (1)

• Rate of successful placement of Tube in the Trachea

  immediately

Secondary Outcomes (3)

• 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

Study Arms (3)

macintosh

ACTIVE COMPARATOR

Device: macintosh laryngoscope

C-MAC

ACTIVE COMPARATOR

Device: C-MAC laryngoscope

Airtraq

ACTIVE COMPARATOR

Device: Airtraq device

Interventions

macintosh laryngoscope DEVICE

intubate with the macintosh laryngoscope

macintosh

C-MAC laryngoscope DEVICE

intubate with the C-MAC laryngoscope

C-MAC

Airtraq device DEVICE

intubate with the Airtraq device

Airtraq

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University College Hospital Galway: lead

Study Sites (1)

Galway University Hospital

Galway, Galway, Ireland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

IE (1)