Electrographic Seizure Management and Neurobehavioral Outcomes in Critically Ill Children

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Seizures

Treatments: Other: Clinically indicated EEG monitoring.

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03419260

17-013808

K02NS096058 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of the efficacy or safety of specific anti-seizure medications or overall management strategies.

This is a single-center prospective observational study. The investigators aim to: (1) track critically ill patients undergoing clinically indicated EEG monitoring and seizure management to identify risk factors for electrographic seizures, (2) create prediction models guiding EEG monitoring resources to the patients at highest risk for seizures, and (3) evaluate our current management strategy in terms of safety.

Full description

Context: Electrographic seizures are common in critically ill patients leading to increased use of resource-intense continuous EEG monitoring for seizure identification and management. When identified, electrographic seizures are generally treated with anti-seizure medications, but there are very limited data available regarding optimal treatment in terms of specific medication selections or overall management strategies. The Children's Hospital of Philadelphia (CHOP) has a formal ICU EEG Monitoring Pathway aiming to standardize EEG monitoring and seizure management. This is a single-center prospective observational study of patients undergoing clinically indicated EEG monitoring to identify risk factors for electrographic seizures and create prediction models guiding limited EEG monitoring resources to the patients at highest risk for seizures, and also to evaluate the current seizure management strategy in terms of safety.

Objectives: The primary objective is to identify risk factors for electrographic seizures in critically ill patients and use these risk factors to create and validate a seizure prediction model. The secondary objective is to evaluate the safety of a targeted and timely electrographic seizure identification and management strategy among critically ill patients guided by a CHOP ICU EEG Monitoring Pathway.

Study Design: Single center observational study of consecutive patients undergoing clinically indicated EEG monitoring.

Setting/Participants: Single-center study of critically ill children in the Pediatric ICU at CHOP undergoing clinically indicated EEG monitoring and seizure management.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Care in the Children's Hospital of Philadelphia Pediatric ICU.
2. Clinically indicated continuous EEG monitoring.
3. Age > 1 month to 18 years.

Exclusion criteria

1. Admitted for Phase 2 (intracranial) EEG monitoring.
2. Intensivist expects to discontinue technological support in the next two days given underlying medical or neurological problems.

Trial design

2,500 participants in 1 patient group

Cohort

Description:

Critically ill child undergoing clinically indicated EEG monitoring and electrographic seizure management.

Treatment:

Other: Clinically indicated EEG monitoring.