CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Automated Somatosensory Evoked Potential device (EPAD@)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03624426
NCT03624426N/ACompleted
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Detection and Prevention of Perioperative Nerve Injury Using Automated Somatosensory Evoked Potential Monitoring in Shoulder Arthroplasty Surgery

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·interventional·Posted Aug 10, 2018·Updated Dec 31, 2020

In Brief

A clinical study evaluating Automated Somatosensory Evoked Potential device (EPAD@) for Neuropathy and Nerve Injury. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuropathy, Nerve Injury
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 10, 2018
Enrollment StartSep 10, 2018
Primary CompletionNov 30, 2019
Study CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.9 years ago

Interventions

Automated Somatosensory Evoked Potential device (EPAD@)device

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.