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Clinical Trials/NCT01032460
NCT01032460
Completed
Not Applicable

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

University College Hospital Galway1 site in 1 country90 target enrollmentJanuary 2010
ConditionsImmobilization

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immobilization
Sponsor
University College Hospital Galway
Enrollment
90
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
November 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University College Hospital Galway

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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

  • 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.(immediatley)
  • Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt(immediately)
  • Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score(immediately)
  • Intubation Difficulty Scale score(immediately)
  • Need for and number of optimisation Manoeuvres to aid tracheal intubation(immediately)

Study Sites (1)

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