Prognostic Value of P30 After Cardiac Arrest

Completed

• Conditions: Out-Of-Hospital Cardiac Arrest

• Registration Number: NCT03175965
• Lead Sponsor: Uijeongbu St. Mary Hospital

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.

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-05
• Study Start: 2017-07-01
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-11
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Comatose survivors after out-of-hospital cardiac arrest

Exclusion Criteria

• Not treated by hypothermic-targeted temperature management

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation	72 hours after ROSC	SEP under the normothermic-TTM without sedation

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Bucheon St. Mary's Hospital; 🇰🇷 Bucheon-si, Gyeonggi-do, Korea, Republic of

Uijeongbu St. Mary's Hospital; 🇰🇷 Uijeongbu-si, Gyeonggi-do, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of