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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03422107
Other study ID # R-16-286
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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