Recruiting

Observational Study

Sponsor:

Children's Hospital at Montefiore

Code:

NCT06564662

Conditions

Status Epilepticus

Coma

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Rapid Response EEG

Study Details

Brief summary:

Seizures are common in children (\~350 per 100,000 patients per year) and require immediate medical attention. If the seizure is prolonged (> 5 minutes) it is called status epilepticus and delayed treatment leads to higher risk in drug resistance and brain injury. The current standard of care for children admitted to the ICU with established or suspected status epilepticus is to start a conventional continuous EEG study that helps diagnosing seizures by typical electro graphic patterns. It takes on average 4 hours to start and another two hours to obtain a reading by epileptologists. This is far beyond the time window of starting an EEG study (60 minutes) as recommended by the neurocritical care society. In adult ICUs, point of care "Rapid Response EEG" are becoming a new standard of care and our ICU adopted this practice in 2020. It can be easily placed by the ICU staff rather than a specifically trained EEG technician but has a lower resolution due to fewer leads (10 vs. 20). The purpose of this study is to determine wether and by how much time RR-EEG yields faster preliminary EEG reports that the previously available conventional EEG (cEEG) and wether the detection of electro graphic seizures is comparable. This is a retrospective cohort study following patients who are admitted to the PICU and are placed on either cEEG or RR-EEG for status epilepticus.

Conditions

Status Epilepticus

Coma

Study ID

NCT06564662

Start date

Dec 9, 2021

Status verified date

Aug, 2024

Completion date

Dec 8, 2026

Anticipated

Primary completion date

Dec 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • all patients with suspected status epilepticus as determined by the treating team in the pediatric ER or ICU

Exclusion Criteria:

  • none

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

Rapid Response EEG

The Ceribell(R) Rapid Response EEG is a relatively new device that is becoming standard of care in the adult critical care. In this pediatric study the device will be placed by trained ICU physicians

Primary outcome measure

  • Time from order of electroencephalogram (EEG) to EEG reading [ Time Frame: up to 24 hours ]

Central Contacts and Locations

Locations

Children's Hospital at Montefiore

Recruiting

Bronx, New York, United States, 10467

Contacts

More Information

Sponsor

Children's Hospital at Montefiore

Last update posted

Aug 21, 2024

Last verified

Aug, 2024

Keywords

  • Electroencephalography
  • Child
  • Intensive Care Units, Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital at Montefiore on 2024-08-21.