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Completed

NCT Number: NCT01032460

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

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.

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Key information

Conditions

Immobilization

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galway University Hospital

Galway, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

intubate with the macintosh laryngoscope

Device

intubate with the macintosh laryngoscope

intubate with the C-MAC laryngoscope

Device

intubate with the C-MAC laryngoscope

intubate with the Airtraq device

Device

intubate with the Airtraq device

Primary outcomes

  1. Rate of successful placement of Tube in the Trachea a. Failed intubation defined as requiring greater than 60s or which resulted in Oesophageal Intubation. b. Successful intubation confirmed by an investigator.

    Time frame: immediately

Secondary outcomes

  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.

    Time frame: immediatley

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

    Time frame: immediately

  3. Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score

    Time frame: immediately

  4. Intubation Difficulty Scale score

    Time frame: immediately

  5. Need for and number of optimisation Manoeuvres to aid tracheal intubation

    Time frame: immediately

Sponsors and collaborators

Lead sponsor

University College Hospital Galway

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 15, 2009
Registry last updated
Nov 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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