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Clinical Trials/NCT03175965
NCT03175965
Completed
Not Applicable

Characteristics of the Somatosensory Evoked Potentials Indicating Poor Neurologic Outcome After Cardiac Arrest

Uijeongbu St. Mary Hospital4 sites in 1 country88 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Out-Of-Hospital Cardiac Arrest
Sponsor
Uijeongbu St. Mary Hospital
Enrollment
88
Locations
4
Primary Endpoint
Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study aims to examine whether P30 wave of somatosensory evoked potentials (SEP) is related with outcome after cardiac arrest. The study design is a prospective, multicenter-observational study. Patients survived after out-of-hospital cardiac arrest undergoing hypothermic-targeted temperature management will participate in the study. Relationship of P30 wave of SEP with the neurologic outcome on hospital discharge will be evaluated.

Detailed Description

The absence of N20 of the somatosensory evoked potentials (SEP) is recommended as a valuable predictor of poor neurologic outcome in post-cardiac arrest patients. However, interpretation of N20 is affected by the background noise levels. Reliable analysis of N20 is limited with high noise levels and artifacts. Moreover, presence of N20 does not guarantee good neurologic outcome. P30 is a positive deflection of N20 occurring on 25-35 msec. According to our pilot study, N20 without following P30 is related with poor outcome, while N20 followed by P30 is highly related with good outcome. P30 is evident even when the N20 is ambiguous in patients with good outcome. We hypothesized that the negative-positive deflection of N20-P30 components is more valuable predictor than the N20 alone. In this observational study, we will identify whether presence of P30 checked on 24 and 72 hours after cardiac arrest predicts neurologic outcome more accurately than the presence of N20 alone.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
November 30, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Uijeongbu St. Mary Hospital
Responsible Party
Principal Investigator
Principal Investigator

Joo Suk Oh, MD. PhD.

Associate Professor

Uijeongbu St. Mary Hospital

Eligibility Criteria

Inclusion Criteria

  • Comatose survivors after out-of-hospital cardiac arrest

Exclusion Criteria

  • Not treated by hypothermic-targeted temperature management

Outcomes

Primary Outcomes

Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation

Time Frame: 72 hours after ROSC

SEP under the normothermic-TTM without sedation

Secondary Outcomes

  • Association of N20 with high amplitude with poor outcome without under the influence of hypothermia and sedation(72 hours after ROSC)
  • Association of abscence of P30 with poor outcome under the influence of hypothermia and sedation(24 hours after ROSC)
  • Association of N20 with high amplitude with poor outcome under the influence of hypothermia and sedation(24 hours after ROSC)

Study Sites (4)

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