Clinical trial NCT03175965: Prognostic Value of P30 After Cardiac Arrest
Official title: Characteristics of the Somatosensory Evoked Potentials Indicating Poor Neurologic Outcome After Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: Heart arrest, hypothermia, SEP, prognosis
Lead sponsor: Uijeongbu St. Mary Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
First posted: 2017-06-05
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 .

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.

Eligibility criteria: Inclusion Criteria:

* Comatose survivors after out-of-hospital cardiac arrest

Exclusion Criteria:

* Not treated by hypothermic-targeted temperature management

Primary outcomes:
measure: Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation
timeFrame: 72 hours after ROSC
Secondary outcomes:
measure: Association of abscence of P30 with poor outcome under the influence of hypothermia and sedation
timeFrame: 24 hours after ROSC
measure: Association of N20 with high amplitude with poor outcome without under the influence of hypothermia and sedation
timeFrame: 72 hours after ROSC
measure: Association of N20 with high amplitude with poor outcome under the influence of hypothermia and sedation
timeFrame: 24 hours after ROSC
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Uijeongbu-si
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's Hospital
Study officials:
affiliation: Uijeongbu St. Mary's Hospital
name: Joo Suk Oh, MD
role: STUDY_CHAIR
References: