What this study is
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.
What's being tested
- Rapid Response EEG
Intervention · DEVICE
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
Study details
- Official title
- Observational Single-Center Study: Improving Timely Detection of Electrographic Seizures by Use of Rapid-Response EEG in Children With Suspected Status Epilepticus Admitted to the Pediatric ICU
- Sponsor
- Children's Hospital at Montefiore
- Conditions
- Status Epilepticus · Coma
- Enrolling
- 60 people
- Starts
- 2021-12-09
- Est. completion
- 2026-12-08
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 2 Years – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- All patients with suspected status epilepticus as determined by the treating team in the pediatric ER or ICU
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's Hospital at Montefiore
The Bronx, New York, United States
- Michael Miksa, MD, PhD · Contact714-484-5123mmiksa@montefiore.org
Recruiting
Study team
Sponsor
Children's Hospital at Montefiore
Study ID MMC-CHAM-PCCM-2021-13666
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.