Prognostic Value of P30 After Cardiac Arrest

Out-Of-Hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175965
• Other study ID #: XC17OEDI0009
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: May 2019
• Source: Uijeongbu St. Mary Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Comatose survivors after out-of-hospital cardiac arrest

Exclusion Criteria:

• Not treated by hypothermic-targeted temperature management

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• Somatosensory evoked potential
Somatosensory evoked potential on 24, 72 hours after cardiac arrest.

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St. Mary's Hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Uijeongbu St. Mary Hospital	The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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