Somatosensory Evoked Potential Algorithm for Detection of Intraoperative Positional Neuropraxia

Neuropraxia Clinical Trial

— EPAD  

Official title:

A Feasibility Study of Integrated SSEP and Detection Algorithm for Detection of Intraoperative Positional Neuropraxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237599
• Other study ID #: 104826
• Status: Completed
• Start date: September 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• elective surgery

Exclusion Criteria:

• neuromuscular disease stroke

Related Conditions & MeSH terms

• Neuropraxia

Locations

Country	Name	City	State
Canada	University Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropraxia	Correlation between postoperative neuropraxia and intraoperative alert of impaired neural transmission detected via EPAD	postoperative