Clinical trial NCT01032460: Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immobilization
Keywords: airway
airway device
cervical spine immobilisation
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: immediately
Secondary outcomes:
measure: 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.
timeFrame: immediatley
measure: Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt
timeFrame: immediately
measure: Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score
timeFrame: immediately
measure: Intubation Difficulty Scale score
timeFrame: immediately
measure: Need for and number of optimisation Manoeuvres to aid tracheal intubation
timeFrame: immediately
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospital
Study officials:
References: