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Somatosensory Evoked Potential Algorithm for Detection of Intraoperative Positional Neuropraxia (EPAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02237599
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : March 5, 2019
Information provided by (Responsible Party):
John Murkin, Lawson Health Research Institute

Brief Summary:
This study hypothesizes that an automated device using small electronic impulses can detect nerve impairment in unconscious patients.

Condition or disease

Detailed Description:
Application of SSEP probes to bilateral ulnar and popliteal nerve areas with sensors at (1) bilateral brachial plexus (clavicles), (2) Erb's point (posterior C8 cervical spine) and (3) on forehead will permit microvolt current to to be detected and analyzed against a proprietary algorithm. Neuropraxia will be detected based on abnormalities developing in received SSEP signals.

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Study Type : Observational
Actual Enrollment : 115 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Feasibility Study of Integrated SSEP and Detection Algorithm for Detection of Intraoperative Positional Neuropraxia
Study Start Date : September 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Primary Outcome Measures :
  1. Neuropraxia [ Time Frame: postoperative ]
    Correlation between postoperative neuropraxia and intraoperative alert of impaired neural transmission detected via EPAD

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intraoperative adult patients undergoing surgical procedure

Inclusion Criteria:

  • elective surgery

Exclusion Criteria:

  • neuromuscular disease stroke

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02237599

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Canada, Ontario
University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: John M Murkin, MD Western University

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Responsible Party: John Murkin, PI, Lawson Health Research Institute Identifier: NCT02237599     History of Changes
Other Study ID Numbers: 104826
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Murkin, Lawson Health Research Institute: