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

Primary Purpose

Spinal Injuries

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
tracheal intubation
Airtraq
fiberscope
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Injuries focused on measuring intubation, difficult airway, fiberscopy, Airtraq, general anesthesia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dpt of Anesthesiology, University of Lausanne CHUV

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tracheal intubation with Fiberscopy

Tracheal intubation with Airtraq

Arm Description

tracheal intubation with a fiberscope

tracheal intubation with an Airtraq

Outcomes

Primary Outcome Measures

Neuromonitoring modifications (modifications appearing on the neuromonitoring)
modifications appearing on the neuromonitoring during the 5 different phases

Secondary Outcome Measures

time necessary for tracheal intubation
tracheal inlet view (best view during intubation)
best view during intubation
number of attempts necessary

Full Information

First Posted
March 3, 2015
Last Updated
December 29, 2017
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02382887
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Injuries
Keywords
intubation, difficult airway, fiberscopy, Airtraq, general anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tracheal intubation with Fiberscopy
Arm Type
Active Comparator
Arm Description
tracheal intubation with a fiberscope
Arm Title
Tracheal intubation with Airtraq
Arm Type
Experimental
Arm Description
tracheal intubation with an Airtraq
Intervention Type
Procedure
Intervention Name(s)
tracheal intubation
Intervention Description
tracheal intubation with the Airtraq
Intervention Type
Device
Intervention Name(s)
Airtraq
Intervention Type
Device
Intervention Name(s)
fiberscope
Primary Outcome Measure Information:
Title
Neuromonitoring modifications (modifications appearing on the neuromonitoring)
Description
modifications appearing on the neuromonitoring during the 5 different phases
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
time necessary for tracheal intubation
Time Frame
180 seconds
Title
tracheal inlet view (best view during intubation)
Description
best view during intubation
Time Frame
10 seconds
Title
number of attempts necessary
Time Frame
180 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Schoettker, MD, PD
Organizational Affiliation
Chief Medical Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt of Anesthesiology, University of Lausanne CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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