Somatosensory Evoked Potential Algorithm for Detection of... | NCT02237599

Studies
Somatosensory Evoked Potential Algorithm for Detection of Intraoperative Positional Neuropraxia

NCT02237599

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Completed

Last Update Posted

Mar 5, 2019Actual

Enrollment

115Actual

Phase

Not provided

Conditions

Neuropraxia

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Sep 10, 2014

First Posted Date

Sep 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2019

Last Update Posted Date

Mar 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Murkin, PI, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neuropraxia	Correlation between postoperative neuropraxia and intraoperative alert of impaired neural transmission detected via EPAD	postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective surgery

Exclusion Criteria:

neuromuscular disease stroke

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Intraoperative adult patients undergoing surgical procedure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John M Murkin, MD	Western University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		London	Ontario	N6A 5A5	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided