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CompletedNCT02458820Updated Jul 9, 2019

Prompt Diagnosis and Treatment of Subclinical Seizures After Cardiac Arrest

An interventional study of DSA EEG in Heart Arrest and Seizures, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 2 Days and older. Per ClinicalTrials.gov, last updated 2019-07-09.

Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
2 Days and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Heart Arrest
  • Seizures

Keywords

  • Cardiopulmonary Resuscitation
  • Return of Spontaneous Circulation
  • ROSC
  • Electroencephalogram
03

In context

Seizures

881 studies on the registry are indexed under Seizures; 143 are open to participants now.

This study's enrollment of 18 is below the median of 64 across 610 interventional studies indexed under Seizures.

Browse Seizures studies →

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Days and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Age \< 48 hours old and \< 38 weeks gestational age
  2. No available computers with DSA software
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • No intervention
    Usual Care

    Patients 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.

  • Experimental
    DSA EEG + Usual Care

    Patients 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.

    Procedure: DSA EEG

Interventions

  • ProcedureDSA EEG

    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.

    Also known as: Color density spectral array electroencephalogram

06

What researchers measure

Primary outcomes

  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.

    Time frame: 3 days

07

Study locations

1 site
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02458820
Lead sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Sponsor
First posted
Jun 1, 2015
Start date
Jun 2015
Primary completion
Jan 2019
Completion
Jan 2019
Last update
Jul 9, 2019

Study contacts

Alexis Topjian, MD, MSCE
principal investigator · Children's Hospital of Philadelphia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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