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

NCT01032460 | Completed

• 1 other identifier: CMAC-3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Immobilization

Keywords

airway; airway device; cervical spine immobilisation

Outcome Measures

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.

  immediately

Secondary Outcomes (5)

• 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 Arms (3)

macintosh

ACTIVE COMPARATOR

Device: intubate with the macintosh laryngoscope

C-MAC

ACTIVE COMPARATOR

Device: intubate with the C-MAC laryngoscope

Airtraq

ACTIVE COMPARATOR

Device: intubate with the Airtraq device

Interventions

intubate with the macintosh laryngoscope DEVICE

intubate with the macintosh laryngoscope

macintosh

intubate with the C-MAC laryngoscope DEVICE

intubate with the C-MAC laryngoscope

C-MAC

intubate with the Airtraq device DEVICE

intubate with the Airtraq device

Airtraq

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1 - 3
• Aged 18 - 85 years
• Written informed Consent
• No relevant drug allergies
• Mallampatti 1 - 2.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College Hospital Galway: lead

Study Sites (1)

Galway University Hospital

Galway, Galway, Ireland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: January 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 9, 2010

Record last verified: 2010-07

Locations

IE (1)