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

Not Applicable

Completed

• Conditions: Immobilization
• Interventions: Device: intubate with the macintosh laryngoscope; Device: intubate with the C-MAC laryngoscope; Device: intubate with the Airtraq device

• Registration Number: NCT01032460
• Lead Sponsor: University College Hospital Galway

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Study Start: 2010-01
• Status Verified: 2010-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-11-08
• Last Update Posted: 2010-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
macintosh	intubate with the macintosh laryngoscope	-
C-MAC	intubate with the C-MAC laryngoscope	-
Airtraq	intubate with the Airtraq device	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Galway University Hospital; 🇮🇪 Galway, Ireland