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

December 29, 2017 updated by: Patrick Schoettker,MD PD, University of Lausanne Hospitals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, 1011
        • Dpt of Anesthesiology, University of Lausanne CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tracheal intubation with Fiberscopy
tracheal intubation with a fiberscope
Procedure: tracheal intubation
tracheal intubation with the Airtraq
Device: fiberscope
Experimental: Tracheal intubation with Airtraq
tracheal intubation with an Airtraq
Procedure: tracheal intubation
tracheal intubation with the Airtraq
Device: Airtraq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuromonitoring modifications (modifications appearing on the neuromonitoring)
Time Frame: 30 seconds
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
Time Frame: 180 seconds
180 seconds
tracheal inlet view (best view during intubation)
Time Frame: 10 seconds
best view during intubation
10 seconds
number of attempts necessary
Time Frame: 180 seconds
180 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Patrick Schoettker, MD, PD, Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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