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Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.

NCT ID: NCT01032460

Last Updated: 2010-11-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-11-30

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 the neck is immobilized.

The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.

These devices may be especially effective in situations where intubation of the trachea is potentially difficult.

The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in situations where the cervical spine is immobilized is not known.

The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC to that of the Macintosh laryngoscope, the gold standard device, in patients in which the cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.

Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh laryngoscope in simulated difficult laryngoscopy.

Detailed Description

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Conditions

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Immobilization

Keywords

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airway airway device cervical spine immobilisation

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

intubate with the macintosh laryngoscope

Intervention Type DEVICE

intubate with the macintosh laryngoscope

C-MAC

Group Type ACTIVE_COMPARATOR

intubate with the C-MAC laryngoscope

Intervention Type DEVICE

intubate with the C-MAC laryngoscope

Airtraq

Group Type ACTIVE_COMPARATOR

intubate with the Airtraq device

Intervention Type DEVICE

intubate with the Airtraq device

Interventions

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intubate with the macintosh laryngoscope

intubate with the macintosh laryngoscope

Intervention Type DEVICE

intubate with the C-MAC laryngoscope

intubate with the C-MAC laryngoscope

Intervention Type DEVICE

intubate with the Airtraq device

intubate with the Airtraq device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASA 1 - 3
* Aged 18 - 85 years
* Written informed Consent
* No relevant drug allergies
* Mallampatti 1 - 2.

Exclusion Criteria

* Patients unable to cooperate with airway assessment (2)
* Patients with predicted difficult intubation

* Mallampatti III or IV
* Thyromental distance \< 6cm
* Mouth opening \< 3.5 cm
* Cervical spine disease
* Anteriorly protruding incisors
* Poor Dentition (2)
* Tumours, polyps or foreign bodies in the upper airway (2)
* Patients with documented difficult airways (2).
* Patients with history of or risk factors for gastric regurgitation (i.e. require rapid sequence induction of anaesthesia)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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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National University of Ireland, Galway

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-3

Identifier Type: -

Identifier Source: org_study_id