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Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery

NCT03624426 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-12-31

No results posted yet for this study

Summary

Up to 5% of total shoulder arthroplasty patients experience transient or permanent nerve injury during surgery. In this study, we will monitor the nerve transmission of the patients' arm to detect whether the nerve is functioning normally. This techniques is called somatosensory evoked potential (SSEP) monitoring. In this study, we will assess whether SSEP monitoring could detect nerve abnormalities, alerts the surgical team enabling optimize their surgical intervention and prevent surgical related nerve injury.

Conditions

Interventions

DEVICE

Automated Somatosensory Evoked Potential device (EPAD@)

After commencement of general anesthesia and during patient positioning, stimulating sensors will be applied to patient wrists and a recording sensor is applied at base of neck posteriorly (at C5 level), forehead and the bilateral wrists. The monitoring will be continued throughout the surgery.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Jason Chui, MBChB · University of Western Ontario, Canada

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2019-11-30
Completion
2020-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03624426 on ClinicalTrials.gov