Skip to content

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

Clinical Assessment of a Novel Automated SSEP Monitor for Detection and Management of Intraoperative Positional Neuropraxia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03422107
Enrollment
100
Registered
2018-02-05
Start date
2017-11-20
Completion date
2019-06-30
Last updated
2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Nerve Injuries, Thoracic Surgery

Keywords

Peripheral Nerve Injuries, Thoracic Surgery, Minimally invasive cardiac surgery

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.

Interventions

None listed

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cumulative duration of abnormal SSEPFrom the beginning of the surgery to the end of surgeryDefined as the amplitude reduction \>50% from baseline, Latency\>10% from baseline

Secondary

MeasureTime frameDescription
The incidence of postoperative peripheral neuropathy at post-operative day 2-5Post operative day 2 to 5The incidence of postoperative peripheral neuropathy at Post-operative day (POD) 2-5, which is diagnosed based on neurological examination
The number of SSEP abnormal alarmsFrom the beginning of the surgery to the end of surgeryThe frequencies the SSEP devise sets off alarms

Countries

Canada

Contacts

Primary ContactSatoru Fujii, MD
satoru.fujii@lhsc.on.ca226-378-2471

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026