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

Spinal Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382887
• Other study ID #: 225/08
• Status: Completed
• Phase: N/A
• First received: March 3, 2015
• Last updated: December 29, 2017
• Start date: March 2009
• Est. completion date: August 1, 2017

Study information

• Verified date: December 2017
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Injuries

Intervention

Procedure:
• tracheal intubation
tracheal intubation with the Airtraq

Device:
• Airtraq

• fiberscope

Locations

Country	Name	City	State
Switzerland	Dpt of Anesthesiology, University of Lausanne CHUV	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuromonitoring modifications (modifications appearing on the neuromonitoring)	modifications appearing on the neuromonitoring during the 5 different phases	30 seconds
Secondary	time necessary for tracheal intubation		180 seconds
Secondary	tracheal inlet view (best view during intubation)	best view during intubation	10 seconds
Secondary	number of attempts necessary		180 seconds