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

This study has been completed.
Sponsor:
Information provided by:
University College Hospital Galway
ClinicalTrials.gov Identifier:
NCT01032460
First received: December 14, 2009
Last updated: November 8, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Immobilization
 Device: intubate with the macintosh laryngoscope
Device: intubate with the C-MAC laryngoscope
Device: intubate with the Airtraq device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College Hospital Galway:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt [ Time Frame: immediately ] [ Designated as safety issue: Yes ]
  • Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score [ Time Frame: immediately ] [ Designated as safety issue: Yes ]
  • Intubation Difficulty Scale score [ Time Frame: immediately ] [ Designated as safety issue: Yes ]
  • Need for and number of optimisation Manoeuvres to aid tracheal intubation [ Time Frame: immediately ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: macintosh Device: intubate with the macintosh laryngoscope
intubate with the macintosh laryngoscope
Active Comparator: C-MAC Device: intubate with the C-MAC laryngoscope
intubate with the C-MAC laryngoscope
Active Comparator: Airtraq Device: intubate with the Airtraq device
intubate with the Airtraq device

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
    • Patients with history of or risk factors for gastric regurgitation (i.e. require rapid sequence induction of anaesthesia)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032460

Locations
Ireland
Galway University Hospital
Galway, Ireland
Sponsors and Collaborators
University College Hospital Galway
  More Information

No publications provided

Responsible Party: John G Laffey, National University of Ireland, Galway
ClinicalTrials.gov Identifier: NCT01032460     History of Changes
Other Study ID Numbers: CMAC-3
Study First Received: December 14, 2009
Last Updated: November 8, 2010
Health Authority: Ireland: Institutional Review Board

Keywords provided by University College Hospital Galway:
airway
airway device
cervical spine immobilisation

ClinicalTrials.gov processed this record on May 19, 2013