Out-Of-Hospital Cardiac ArrestNCT03175965
Prognostic Value of P30 After Cardiac Arrest
An observational study of Out-Of-Hospital Cardiac Arrest, run by Uijeongbu St. Mary Hospital at 4 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Somatosensory evoked potential
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 1 Jul 2017to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out-of-hospital cardiac arrest patients undergoing hypothermic-targeted temperature management in the four academically affiliated tertiary care centers .
Who may be able to join
- Comatose survivors after out-of-hospital cardiac arrest
Who cannot join
- Not treated by hypothermic-targeted temperature management
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
Seoul St. Mary's Hospital
Seoul, 06591
Yeouido St. Mary's Hospital
Seoul, 07345
Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 11765
About this study
Official title: Characteristics of the Somatosensory Evoked Potentials Indicating Poor Neurologic Outcome 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.
Read the 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.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Somatosensory evoked potential
- Keywords
- Heart arrest, hypothermia, SEP, prognosis
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatosensory evoked potentialDevice
Somatosensory evoked potential on 24, 72 hours after cardiac arrest.
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation
SEP under the normothermic-TTM without sedation
Measured: 72 hours after ROSC
Secondary outcomes (3)
Association of abscence of P30 with poor outcome under the influence of hypothermia and sedation
SEP under the hypothermic-TTM with sedation
Measured: 24 hours after ROSC
Association of N20 with high amplitude with poor outcome without under the influence of hypothermia and sedation
SEP under the normothermic-TTM without sedation
Measured: 72 hours after ROSC
Association of N20 with high amplitude with poor outcome under the influence of hypothermia and sedation
SEP under the hypothermic-TTM with sedation
Measured: 24 hours after ROSC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Jul 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uijeongbu St. Mary Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea
- Responsible party
- Principal investigator, Joo Suk Oh, MD. PhD., Uijeongbu St. Mary Hospital
- Investigators
- Joo Suk Oh, MD, Study chair, Uijeongbu St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175965
- Sponsor's protocol ID
- XC17OEDI0009
- Status last verified
- May 2019
- First submitted
- 31 May 2017
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of the Somatosensory Evoked Potentials Indicating Poor Neurologic Outcome After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03175965
- Acronym / sponsor ID
- XC17OEDI0009
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Heart arrest, hypothermia, SEP, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Uijeongbu St. Mary HospitalUniversity, hospital or other
- Collaborators
- The Catholic University of Korea
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out-of-hospital cardiac arrest patients undergoing hypothermic-targeted temperature management in the four academically affiliated tertiary care centers .
Key inclusion criteria (1 listed)
- Comatose survivors after out-of-hospital cardiac arrest
Key exclusion criteria (1 listed)
- Not treated by hypothermic-targeted temperature management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatosensory evoked potentialSomatosensory evoked potential on 24, 72 hours after cardiac arrest. | Device | – |
Primary outcome
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
3 secondary outcomes
Association of abscence of P30 with poor outcome under the influence of hypothermia and sedation
Time frame: 24 hours after ROSC
Association of N20 with high amplitude with poor outcome without under the influence of hypothermia and sedation
Time frame: 72 hours after ROSC
Association of N20 with high amplitude with poor outcome under the influence of hypothermia and sedation
Time frame: 24 hours after ROSC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Suk Oh, MD study chair
Uijeongbu St. Mary's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by Uijeongbu St. Mary Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation (time frame: 72 hours after ROSC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.