Prognostic Value of P30 After Cardiac Arrest

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

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.

Study Overview

• Status: Completed
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Device: Somatosensory evoked potential

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.

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Seoul st. mary's hospital
  • Seoul, Korea, Republic of, 07345
    • Yeouido St. Mary's Hospital
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
      • Bucheon St. Mary's Hospital
    • Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 11765
      • Uijeongbu St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Out-of-hospital cardiac arrest patients undergoing hypothermic-targeted temperature management in the four academically affiliated tertiary care centers .

Description

Inclusion Criteria:

• Comatose survivors after out-of-hospital cardiac arrest

Exclusion Criteria:

• Not treated by hypothermic-targeted temperature management

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation	SEP under the normothermic-TTM without sedation	72 hours after ROSC

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of abscence of P30 with poor outcome under the influence of hypothermia and sedation	SEP under the hypothermic-TTM with sedation	24 hours after ROSC
Association of N20 with high amplitude with poor outcome without under the influence of hypothermia and sedation	SEP under the normothermic-TTM without sedation	72 hours after ROSC
Association of N20 with high amplitude with poor outcome under the influence of hypothermia and sedation	SEP under the hypothermic-TTM with sedation	24 hours after ROSC

Collaborators and Investigators

• Sponsor: Uijeongbu St. Mary Hospital
• Collaborators: The Catholic University of Korea
• Investigators: Study Chair: Joo Suk Oh, MD, Uijeongbu St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (ACTUAL): June 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 11, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Heart arrest, hypothermia, SEP, prognosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: XC17OEDI0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes