Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine

Study Overview
=================
Brief Summary
-----------------
Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery. Commonly, the management of the tracheal intubation is performed by a fiberoptic technique. However, changes in equipment availability and quality may challenge the fiberoptic intubation technique. The investigators wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.

Detailed Description
-----------------
Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery. Commonly, the management of the tracheal intubation is performed by a fiberoptic technique (historic gold standard technique). However, changes in equipment availability and quality may challenge the fiberoptic intubation technique. We wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique. Primary outcomes will be the changes in neurophysiologic responses monitored by a neurophysiologist in 5 specific phases: Basal potential (BM): neuromonitoring while the patient is anesthetized, no movements Ventilation potential (VM): neuromonitoring while the patient is anesthetized and a bag-mask ventilation is performed Intubation potential (IP): neuromonitoring while the patient is being intubated with one of the two randomized devices Post Intubation (PI): neuromonitoring after the patient has been intubated Post Positioning (PP): neuromonitoring after the patient has been properly positioned on the operating table and is ready for surgery

Official Title
-----------------
Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine

Conditions
-----------------
Spinal Injuries

Intervention / Treatment
-----------------
* Procedure: tracheal intubation
* Device: Airtraq
* Device: fiberscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unstable cervical spine due to a cervical vertebra fracture American Society of Anesthesia classification 1-3 BMI < 30 kg/m2 patients necessitating a general anesthesia for surgery Exclusion Criteria: patient refusal ASA >3 mouth opening < 15mm patients with known history of previous orotracheal tumor surgery

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tracheal intubation with Fiberscopy<br>tracheal intubation with a fiberscope | Procedure: tracheal intubation<br>* tracheal intubation with the Airtraq<br>Device: fiberscope<br> <br> |
| Experimental: Tracheal intubation with Airtraq<br>tracheal intubation with an Airtraq | Procedure: tracheal intubation<br>* tracheal intubation with the Airtraq<br>Device: Airtraq<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuromonitoring modifications (modifications appearing on the neuromonitoring) | modifications appearing on the neuromonitoring during the 5 different phases | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time necessary for tracheal intubation |  | 180 seconds | 
| tracheal inlet view (best view during intubation) | best view during intubation | 10 seconds | 
| number of attempts necessary |  | 180 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, difficult airway, fiberscopy, Airtraq, general anesthesia