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

NCT ID: NCT01031940

Last Updated: 2012-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Airway Difficult Intubation Airway Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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macintosh

Group Type ACTIVE_COMPARATOR

macintosh laryngoscope

Intervention Type DEVICE

intubate with the macintosh laryngoscope

C-MAC

Group Type ACTIVE_COMPARATOR

C-MAC laryngoscope

Intervention Type DEVICE

intubate with the C-MAC laryngoscope

Airtraq

Group Type ACTIVE_COMPARATOR

Airtraq device

Intervention Type DEVICE

intubate with the Airtraq device

Interventions

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macintosh laryngoscope

intubate with the macintosh laryngoscope

Intervention Type DEVICE

C-MAC laryngoscope

intubate with the C-MAC laryngoscope

Intervention Type DEVICE

Airtraq device

intubate with the Airtraq device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Hospital Galway

OTHER

Sponsor Role lead

Responsible Party

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John Laffey

Professor of Anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Galway University Hospital

Galway, Galway, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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CMAC-1

Identifier Type: -

Identifier Source: org_study_id

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