Somatosensory Evoked Potential (SSEP) Monitoring for Detection of Intraoperative Positional Neuropraxia

• Conditions: Thoracic Surgery; Peripheral Nerve Injuries

• Registration Number: NCT03422107
• Lead Sponsor: Western University, Canada

Brief Summary

PNI (Peripheral Nerve Injury) occurs in 5-15% of patients in cardiac surgery. So far, the mechanism of injury has never been researched. In this study, we will compare minimally invasive cardiac surgery with conventional cardiac surgery using a novel portable SSEP device to pinpoint the mechanism and timing of PNI during cardiac surgery.

Detailed Description

General objectives The general objective of this study is to identify the causative insults during various kinds of cardiac surgeries. To attain this objective, we have three specific aims. Firstly, surgical insults such as excessive or asymmetric sternal retraction have long been regarded as the main causes of PNI. Therefore, we will investigate this by comparing cardiac surgeries with sternotomy to the ones without sternotomy. Secondly, more and more cardiac surgeons utilize minimally invasive techniques these days. In the current study, we will investigate the incidence, mechanisms and patterns of PNI in minimally invasive cardiac surgeries by comparing conventional surgeries to minimally invasive surgeries. Thirdly, recent studies have suggested systematic insults such as ischemia, inflammation, and underlying neuropathy might play more prominent roles in the mechanism of PNI. In this study, we will analyze various factors such as intraoperative hemodynamics and baseline patient characteristics to pinpoint the most responsible factors.

Background The studies regarding mechanisms of PNI in cardiac surgeries have not been done over the past few decades. With respect to minimally invasive cardiac surgeries, no studies have been done to investigate the mechanism of PNI.

Regarding the device used in this study The conventional SSEP device is large in size, invasive, and requires expertise to interpret. These characteristics have prevented its use in the operating room. This new portable SSEP device is devoid of these properties.

Significance Identification of causative insults will help clinicians to recognize and possibly prevent PNI during cardiac surgeries.

Study Timeline

• Study Start: 2017-11-20
• Status Verified: 2018-01
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-12
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

●all adult (age>18, <95 years of age) cardiac surgical patients who are undergoing the four following procedures, open AVR, TAVI, conventional CABG, robotic CABG

Exclusion Criteria

• any patients with contraindication to SSEP monitoring, which include skin burns or trauma at SSEP electrode sites
• lack of written consent
• emergency surgery
• language barrier
• fluctuating neurological signs/symptoms
• regional anesthesia (spinal, epidural, nerve block)
• CABG with radial artery harvest, combined cardiac surgeries

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative duration of abnormal SSEP	From the beginning of the surgery to the end of surgery	Defined as the amplitude reduction \>50% from baseline, Latency\>10% from baseline

Secondary Outcome Measures

Name	Time	Method
The incidence of postoperative peripheral neuropathy at post-operative day 2-5	Post operative day 2 to 5	The incidence of postoperative peripheral neuropathy at Post-operative day (POD) 2-5, which is diagnosed based on neurological examination
The number of SSEP abnormal alarms	From the beginning of the surgery to the end of surgery	The frequencies the SSEP devise sets off alarms

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada