Prompt Diagnosis and Treatment of Subclinical Seizures After Cardiac Arrest

NCT02458820 | Completed

• 2 other identifiers: 14-0116355K23NS075363
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Arrest; Seizures

Keywords

Cardiopulmonary Resuscitation; Return of Spontaneous Circulation; ROSC; Electroencephalogram

Outcome Measures

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.

  3 days

Study Arms (2)

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.

Procedure: DSA EEG

Interventions

DSA EEG PROCEDURE

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

DSA EEG + Usual Care

Eligibility Criteria

• Age: 2 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Arrest; Seizures

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexis Topjian, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

US (1)