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
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
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
NCT ID
NCT02382887
First Posted
March 3, 2015
Last Updated
December 29, 2017
Sponsor
University of Lausanne Hospitals
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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