Somatosensory Evoked Potential (SSEP) Monitoring for Detection of

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03422107
Study type	Observational
Source	Western University, Canada
Contact	Satoru Fujii, MD
Phone	226-378-2471
Email	satoru.fujii@lhsc.on.ca
Status	Recruiting
Phase	N/A
Start date	November 20, 2017
Completion date	June 30, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms