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

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ClinicalTrials.gov Identifier: NCT02237599
Recruitment Status : Recruiting
First Posted : September 11, 2014
Last Update Posted : August 21, 2018
Sponsor:
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
Neuropraxia

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.

Study Type : Observational
Estimated Enrollment : 150 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
Estimated Primary Completion Date : December 2018
Estimated 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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02237599


Contacts
Contact: Robert Mayer, MSc 519-685-8500 ext 34307 robert.mayer@lhsc.on.ca

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

Responsible Party: John Murkin, PI, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02237599     History of Changes
Other Study ID Numbers: 104826
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Murkin, Lawson Health Research Institute:
SSEP
neuropraxia
intraoperative
automated