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

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03422107
• Other study ID #: R-16-286
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2018
• Last updated: March 8, 2018
• Start date: November 20, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2018
• Source: Western University, Canada
• Contact: Satoru Fujii, MD
• Phone: 226-378-2471
• Email: satoru.fujii[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Thoracic Surgery

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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