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Prognostic Value of P30 After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT03175965
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
The Catholic University of Korea
Information provided by (Responsible Party):
Joo Suk Oh, MD. PhD., 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.

Condition or disease Intervention/treatment
Out-Of-Hospital Cardiac Arrest 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
Estimated Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics of the Somatosensory Evoked Potentials Indicating Poor Neurologic Outcome After Cardiac Arrest
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
Criteria

Inclusion Criteria:

  • Comatose survivors after out-of-hospital cardiac arrest

Exclusion Criteria:

  • Not treated by hypothermic-targeted temperature management

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175965


Contacts
Contact: Joo Suk Oh, MD 82-10-4379-4197 erkeeper@catholic.ac.kr

Locations
Korea, Republic of
Bucheon St. Mary's Hospital Recruiting
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
Contact: Ji Hoon Kim, MD         
Principal Investigator: Ji Hoon Kim, MD         
Uijeongbu St. Mary's Hospital Recruiting
Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 11765
Contact: Joo Suk Oh, MD    82-10-4379-4197    erkeeper@catholic.ac.kr   
Principal Investigator: Joo Suk Oh, MD         
Sub-Investigator: Jungtaek Park, MD         
Sub-Investigator: Hyun Ho Jung, MD         
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Sang Hoon Oh, MD         
Principal Investigator: Kyu Nam Park, MD         
Sub-Investigator: Sang Hoon Oh, MD         
Yeouido St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 07345
Contact: Jung Hee Wee, MD         
Principal Investigator: Seung Pil Choi, MD         
Sub-Investigator: Jung Hee Wee, MD         
Sponsors and Collaborators
Uijeongbu St. Mary Hospital
The Catholic University of Korea
Investigators
Study Chair: Joo Suk Oh, MD Uijeongbu St. Mary's Hospital

Responsible Party: Joo Suk Oh, MD. PhD., Associate Professor, Uijeongbu St. Mary Hospital
ClinicalTrials.gov Identifier: NCT03175965     History of Changes
Other Study ID Numbers: XC17OEDI0009
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Joo Suk Oh, MD. PhD., Uijeongbu St. Mary Hospital:
Heart arrest, hypothermia, SEP, prognosis

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases