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

Clinical Assessment of a Novel Automated SSEP Monitor for Detection and Management of Intraoperative Positional Neuropraxia

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.

Study Overview

• Status: Unknown
• Conditions: Thoracic Surgery; Peripheral Nerve Injuries

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Satoru Fujii, MD; Phone Number: 226-378-2471; Email: satoru.fujii@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • London Health Sciences Centre
      • Contact: Satoru Fujii, MD; Phone Number: 13302 519-685-8500; Email: satoru.fujii@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Our inclusion criteria are all adult (age>18 years of age) cardiac surgical patients who are undergoing the four following procedures, open AVR, TAVI, conventional CABG, robotic CABG. This 4 groups of patients represent 4 different combination of potential surgical insults- median sternotomy, Internal thoracic artery (ITA) retraction, ITA harvesting, cardiopulmonary bypass and positioning

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
TAVI; Transcatheter Aortic Valve Implantation
cAVR; Conventional Valve Replacement
rCABG; minimally invasive coronary artery bypass graft
cCABG; Conventional Coronary Artery Bypass Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative duration of abnormal SSEP	Defined as the amplitude reduction >50% from baseline, Latency>10% from baseline	From the beginning of the surgery to the end of surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Western University, Canada
• Investigators: Study Director: John Murkin, MD, Western University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Thoracic Surgery; Peripheral Nerve Injuries; Minimally invasive cardiac surgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: R-16-286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No