Clinical trial NCT02382887: Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine
Official title: Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Injuries
Keywords: intubation
difficult airway
fiberscopy
Airtraq
general anesthesia
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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

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

Primary outcomes:
measure: Neuromonitoring modifications (modifications appearing on the neuromonitoring)
timeFrame: 30 seconds
Secondary outcomes:
measure: time necessary for tracheal intubation
timeFrame: 180 seconds
measure: tracheal inlet view (best view during intubation)
timeFrame: 10 seconds
measure: number of attempts necessary
timeFrame: 180 seconds
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Dpt of Anesthesiology, University of Lausanne CHUV
state: VD
Study officials:
affiliation: Chief Medical Officer
name: Patrick Schoettker, MD, PD
role: PRINCIPAL_INVESTIGATOR
References: