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

Immobilization Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032460
• Other study ID #: CMAC-3
• Status: Completed
• Phase: N/A
• First received: December 14, 2009
• Last updated: November 8, 2010
• Start date: January 2010
• Est. completion date: November 2010

Study information

• Verified date: July 2010
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Immobilization

Intervention

Device:
• intubate with the macintosh laryngoscope
intubate with the macintosh laryngoscope
• intubate with the C-MAC laryngoscope
intubate with the C-MAC laryngoscope
• intubate with the Airtraq device
intubate with the Airtraq device

Locations

Country	Name	City	State
Ireland	Galway University Hospital	Galway

Sponsors (1)

Lead Sponsor	Collaborator
University College Hospital Galway

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt		immediately	Yes
Secondary	Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score		immediately	Yes
Secondary	Intubation Difficulty Scale score		immediately	Yes
Secondary	Need for and number of optimisation Manoeuvres to aid tracheal intubation		immediately	Yes