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

NCT ID: NCT03422107

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-20
• Study Completion Date: 2019-06-30

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.

Conditions

Peripheral Nerve Injuries; Thoracic Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TAVI

Transcatheter Aortic Valve Implantation

No interventions assigned to this group

cAVR

Conventional Valve Replacement

No interventions assigned to this group

rCABG

minimally invasive coronary artery bypass graft

No interventions assigned to this group

cCABG

Conventional Coronary Artery Bypass Graft

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Murkin, MD

Role: STUDY_DIRECTOR

Western University

Locations

London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Satoru Fujii, MD

Role: CONTACT

satoru.fujii@lhsc.on.ca

226-378-2471

Facility Contacts

Satoru Fujii, MD

Role: primary

satoru.fujii@lhsc.on.ca

519-685-8500 ext. 13302

Other Identifiers

R-16-286

Identifier Type: -

Identifier Source: org_study_id