Prompt Diagnosis and Treatment of Subclinical Seizures After Cardiac Arrest
Status: | Recruiting |
---|---|
Conditions: | Cardiology, Neurology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
Healthy: | No |
Age Range: | Any |
Updated: | 12/16/2018 |
Start Date: | June 2015 |
End Date: | June 2019 |
Contact: | Alexis Topjian, MD, MSCE |
Email: | topjian@chop.edu |
Phone: | 215-590-3915 |
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.
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.
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.
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.
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:
1. Age < 48 hours old and < 38 weeks gestational age
2. No available computers with DSA software
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 215-590-3915
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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