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

Lausanne University Hospital (CHUV)

Status: Completed

Conditions: Spinal Injuries

Treatments: Device: Airtraq; Procedure: tracheal intubation; Device: fiberscope

Study type: Interventional

Funder types: Other

Identifiers

NCT02382887

225/08

Details and patient eligibility

About

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.

Full 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:

1. Basal potential (BM): neuromonitoring while the patient is anesthetized, no movements
2. Ventilation potential (VM): neuromonitoring while the patient is anesthetized and a bag-mask ventilation is performed
3. Intubation potential (IP): neuromonitoring while the patient is being intubated with one of the two randomized devices
4. Post Intubation (PI): neuromonitoring after the patient has been intubated
5. Post Positioning (PP): neuromonitoring after the patient has been properly positioned on the operating table and is ready for surgery

Enrollment: 40 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Tracheal intubation with Fiberscopy

Active Comparator group

Description:

tracheal intubation with a fiberscope

Treatment:

Device: fiberscope

Procedure: tracheal intubation

Tracheal intubation with Airtraq

Experimental group

Description:

tracheal intubation with an Airtraq

Treatment:

Device: Airtraq

Procedure: tracheal intubation