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Heart ArrestNCT02458820

Prompt Diagnosis and Treatment of Subclinical Seizures After Cardiac Arrest

A study testing DSA EEG in people with Heart Arrest and Seizures, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Non-convulsive seizures (NCS) following cardiac arrest are common and are associated with worse neurologic outcomes and increased mortality. More prolonged seizures (status epilepticus) are associated with worse outcomes. Read more about this study

Who is it for?
Ages 2 days and older
Conditions the study is for
Heart Arrest, Seizures
What is being tested?
DSA EEG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Jun 2015to Jan 2019
Phase
Interventional
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 2 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subjects age > 48 hours
  • Return of Spontaneous Circulation (ROSC) for > 20 minutes after a cardiac arrest
  • Treated in the PICU
  • Clinical team ordering continuous EEG monitoring

Who cannot join

  • Age < 48 hours old and < 38 weeks gestational age
  • No available computers with DSA software

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Non-convulsive seizures (NCS) following cardiac arrest are common and are associated with worse neurologic outcomes and increased mortality. More prolonged seizures (status epilepticus) are associated with worse outcomes. Earlier diagnosis and treatment of seizures may lead to earlier termination of seizures and decreased seizure burden.

This study will evaluate whether bedside intensive care unit (ICU) provider interpretation of a type of EEG called DSA EEG can be used by non-neurologists to diagnosis seizures more rapidly than continuous EEG's routinely read by neurologists.

Read the detailed description

Acute symptomatic electroencephalographic (EEG) seizures are common in children who experience a cardiac arrest, and are associated with worse short term survival. In larger studies of critically ill children with heterogeneous acute encephalopathy etiologies, EEG seizures occur in 10-40% of monitored patients, and there is increasing evidence that high seizure burdens are associated with worse outcomes. Furthermore, status epilepticus treatment delays are associated with reduced medication efficacy for status epilepticus termination. The majority of EEG seizures in critically ill children have no clinical correlate and therefore detection requires EEG monitoring. Many institutions do not have access to continuous EEG monitoring services. Additionally, even when EEG "monitoring" is performed, data review is generally intermittent, leading to delays between seizure onset and detection.The purpose of the study is to determine the efficacy of real-time DSA pattern interpretation for the detection of seizures by bedside ICU practitioners.The primary objective of this study is to determine the whether the real-time DSA patterns interpreted by bedside ICU practitioners can decrease the time to accurate NCS detection following pediatric cardiac arrest. All subjects who receive chest compressions and have return of spontaneous circulation and are cared for the CHOP Pediatric Intensive Care Unit (PICU) will be screened. If patients meet inclusion criteria they will be approached for consent. Written informed consent will be obtained from parents/guardians. Assent will not be obtained as these children are intubated and comatose after arrest.Patients will be randomly assigned to receive standard of care, continuous EEG monitoring, versus continuous EEG monitoring plus real-time ICU provider DSA interpretation. This will go on for the duration of clinically indicated EEG monitoring.

For patients enrolled in the standard continuous EEG arm of the study, EEG will be recorded and interpreted as per standard of care. If a seizure is noted by the neurology service, the standard seizure treatment protocol will be used by the clinical team.Patients monitored with standard EEG and DSA will undergo at least hourly interpretation of DSA by the ICU bedside care provider. If the bedside care provider is concerned that there is a seizure on DSA they will contact the EEG tech on call for confirmation. If a seizure is confirmed by neurology, the standard seizure treatment protocol will be used by the clinical team.Following completion of EEG intervention arms, the patients will be followed and discharge survival and discharge Pediatric Cerebral Performance Category (PCPC) will be documented.

Being tested
DSA EEG
Keywords
Cardiopulmonary Resuscitation, Return of Spontaneous Circulation, ROSC, Electroencephalogram
Medical subject headings
Heart Arrest, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSA EEGProcedure or surgery

    Also called Color density spectral array electroencephalogram

    Color density spectral array (DSA) is a quantitative electroencephalogram (EEG) technique that uses Fourier transformation to present EEG power (amplitude2/Hz, by color) and frequency (y-axis) over time (x-axis). It is commercially available and used routinely by neurophysiologists for EEG interpretation. Up to several hours of EEG can be displayed as a single image.

Study groups in NCT02458820
Study groupRoleWhat they receive
Usual CareNo interventionPatients will be recorded and interpreted as per standard of care. If a seizure is noted by the neurology service, the standard seizure treatment protocol will be used by the clinical team.
DSA EEG + Usual CareExperimentalPatients will undergo at least hourly interpretation of DSA by the ICU bedside care provider. If the bedside care provider is concerned that there is a seizure on DSA they will contact the EEG tech on call for confirmation. If a seizure is confirmed by neurology, the standard seizure treatment protocol will be used by the clinical team.
Receives: Procedure: DSA EEG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average time from EEG seizure onset to seizure recognition

    EEG monitoring and DSA interpretation by ICU practitioners will continue for the duration of clinically indicated EEG monitoring which will be no more than 3 days. The average time from seizure onset to seizure recognition between the EEG group and the EEG + DSA group will be compared.

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02458820
Sponsor's protocol ID
14-011635
Other IDs
5K23NS075363
Status last verified
Jul 2019
First submitted
28 May 2015
Last updated
9 Jul 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing DSA EEG in people with Heart Arrest and Seizures, run by Children's Hospital of Philadelphia at 1 site in United States.

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 4 inclusion and 2 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Average time from EEG seizure onset to seizure recognition (time frame: 3 days). 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 9 Jul 2019.

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