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

University College Hospital Galway

Status: Completed

Conditions: Immobilization

Treatments: Device: intubate with the Airtraq device; Device: intubate with the C-MAC laryngoscope; Device: intubate with the macintosh laryngoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT01032460

CMAC-3

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

macintosh

Active Comparator group

Treatment:

Device: intubate with the macintosh laryngoscope

C-MAC

Active Comparator group

Treatment:

Device: intubate with the C-MAC laryngoscope

Airtraq

Active Comparator group

Treatment:

Device: intubate with the Airtraq device