Recruiting

Somatosensory Evoked Potential

Sponsor:

Western University, Canada

Code:

NCT03422107

Conditions

Peripheral Nerve Injuries

Thoracic Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03422107

Start date

Nov 20, 2017

Status verified date

Jan, 2018

Completion date

Jun 30, 2019

Anticipated

Primary completion date

Dec 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

TAVI

Transcatheter Aortic Valve Implantation

cAVR

Conventional Valve Replacement

rCABG

minimally invasive coronary artery bypass graft

cCABG

Conventional Coronary Artery Bypass Graft

Primary outcome measure

  • Cumulative duration of abnormal SSEP [ Time Frame: From the beginning of the surgery to the end of surgery ]

Central Contacts and Locations

Central contacts

Satoru Fujii, MD

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

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Satoru Fujii, MD

519-685-8500satoru.fujii@lhsc.on.ca

More Information

Sponsor

Western University, Canada

Last update posted

Mar 12, 2018

Last verified

Jan, 2018

Keywords

  • Peripheral Nerve Injuries
  • Thoracic Surgery
  • Minimally invasive cardiac surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2018-03-12.