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Completed

NCT Number: NCT03175965

Prognostic Value of P30 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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Body Temperature Changes Cardiovascular Diseases Heart Arrest Heart Diseases Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bucheon St. Mary's Hospital, Bucheon-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Comatose survivors after out-of-hospital cardiac arrest

Exclusion criteria

  • Not treated by hypothermic-targeted temperature management

Treatment and study plan

Somatosensory evoked potential

Device

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

Primary outcomes

  1. 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

  1. Association of abscence of P30 with poor outcome under the influence of hypothermia and sedation

    Time frame: 24 hours after ROSC

    SEP under the hypothermic-TTM with sedation

  2. Association of N20 with high amplitude with poor outcome without under the influence of hypothermia and sedation

    Time frame: 72 hours after ROSC

    SEP under the normothermic-TTM without sedation

  3. Association of N20 with high amplitude with poor outcome under the influence of hypothermia and sedation

    Time frame: 24 hours after ROSC

    SEP under the hypothermic-TTM with sedation

Sponsors and collaborators

Lead sponsor

Uijeongbu St. Mary Hospital

Other

Collaborators

  • The Catholic University of Korea

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2017
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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