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.

Study Overview

• Status: Completed
• Conditions: Immobilization
• Intervention / Treatment: Device: intubate with the macintosh laryngoscope; Device: intubate with the C-MAC laryngoscope; Device: intubate with the Airtraq device

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Galway University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	immediately

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University College Hospital Galway

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): November 1, 2010

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (ESTIMATE): December 15, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 9, 2010
• Last Update Submitted That Met QC Criteria: November 8, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: airway; airway device; cervical spine immobilisation
• Other Study ID Numbers: CMAC-3