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OpenTrials
Completed

NCT Number: NCT02382887

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dpt of Anesthesiology, University of Lausanne CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tracheal intubation

Procedure

tracheal intubation with the Airtraq

Airtraq

Device

fiberscope

Device

Primary outcomes

  1. Neuromonitoring modifications (modifications appearing on the neuromonitoring)

    Time frame: 30 seconds

    modifications appearing on the neuromonitoring during the 5 different phases

Secondary outcomes

  1. time necessary for tracheal intubation

    Time frame: 180 seconds

  2. tracheal inlet view (best view during intubation)

    Time frame: 10 seconds

    best view during intubation

  3. number of attempts necessary

    Time frame: 180 seconds

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2015
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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