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.
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
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.
- Conditions
- Heart Arrest, Seizures
- 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 group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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. |
| DSA EEG + Usual Care | Experimental | 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. Receives: Procedure: DSA EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted1 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Topjian, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prompt Diagnosis and Treatment of Subclinical Seizures After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02458820
- Acronym / sponsor ID
- 14-011635
- Conditions
- Heart Arrest, Seizures
- Keywords
- Cardiopulmonary Resuscitation, Return of Spontaneous Circulation, ROSC, Electroencephalogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 1 Jun 2015 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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. |
| DSA EEG + Usual Care | Experimental | Procedure: DSA EEGPatients 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. |
Who may qualify
- Ages
- 2 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 48 hours old and < 38 weeks gestational age
- No available computers with DSA software
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 |
|---|---|---|
| DSA EEGAlso: Color density spectral array electroencephalogramColor 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. | Procedure or surgery | DSA EEG + Usual Care |
Primary outcome
Average time from EEG seizure onset to seizure recognition
Time frame: 3 days
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.
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 9 Jul 2019.
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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.
Alexis Topjian, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
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.