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

NCT03422107 | Unknown

• 1 other identifier: R-16-286
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nerve Injuries; Thoracic Surgery

Keywords

Peripheral Nerve Injuries; Thoracic Surgery; Minimally invasive cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The incidence of postoperative peripheral neuropathy at post-operative day 2-5

  Post operative day 2 to 5

• The number of SSEP abnormal alarms

  From the beginning of the surgery to the end of surgery

Study Arms (4)

TAVI

Transcatheter Aortic Valve Implantation

cAVR

Conventional Valve Replacement

rCABG

minimally invasive coronary artery bypass graft

cCABG

Conventional Coronary Artery Bypass Graft

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ●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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• John Murkin, MD

  Western University

  STUDY DIRECTOR

Central Study Contacts

Satoru Fujii, MD

CONTACT

226-378-2471; satoru.fujii@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: November 20, 2017
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: March 12, 2018

Record last verified: 2018-01

Locations

CA (1)