Status Epilepticus Clinical Trial
Official title:
The Role of Point-of-care EEG in the Pediatric Emergency Department
The researchers investigate the use of a simplified electroencephalogram (point-of-care EEG) in the pediatric emergency department for children with impaired consciousness or an ongoing epileptic seizure ("status epilepticus"). In addition, the researchers will compare the simplified EEG with the conventional EEG in the epilepsy outpatient clinic.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 1, 2025 |
Est. primary completion date | August 23, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: General: PED: - Pediatric patients with unexplained impaired consciousness, suspicion of NCSE, active SE presenting to the PED - Informed consent of patient of parents/persons responsible, if possible, otherwise emergency situation procedure (according to national regulations for research in emergency situations) CLINIC: - Informed consent as documented by signature - Pediatric patients undergoing cEEG in the outpatient epilepsy clinics - Either suspected/ to rule out epilepsy or established diagnosis of epilepsy Exclusion Criteria: PED: - AMS of known etiology or another diagnosis - Declined informed consent CLINIC: - Failure to provide signed informed consent - Changes in health condition which might interfere with the EEG recording. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Children's Hospital Zurich | Zürich |
Lead Sponsor | Collaborator |
---|---|
University Children's Hospital, Zurich | Pediatric Emergency Department, Inselspital Bern, Switzerland, Pediatric Neurology Department, Inselspital Bern, Switzerland (Dr. Sanchez-Albisua) |
Switzerland,
Nozawa M, Terashima H, Tsuji S, Kubota M. A Simplified Electroencephalogram Monitoring System in the Emergency Room. Pediatr Emerg Care. 2019 Jul;35(7):487-492. doi: 10.1097/PEC.0000000000001033. — View Citation
Simma L, Bauder F, Schmitt-Mechelke T. Feasibility and usefulness of rapid 2-channel-EEG-monitoring (point-of-care EEG) for acute CNS disorders in the paediatric emergency department: an observational study. Emerg Med J. 2021 Dec;38(12):919-922. doi: 10.1136/emermed-2020-209891. Epub 2020 Oct 30. — View Citation
Yamaguchi H, Nagase H, Nishiyama M, Tokumoto S, Ishida Y, Tomioka K, Tanaka T, Fujita K, Toyoshima D, Nishimura N, Kurosawa H, Nozu K, Maruyama A, Tanaka R, Iijima K. Nonconvulsive Seizure Detection by Reduced-Lead Electroencephalography in Children with Altered Mental Status in the Emergency Department. J Pediatr. 2019 Apr;207:213-219.e3. doi: 10.1016/j.jpeds.2018.11.019. Epub 2018 Dec 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants diagnosed with SE, NCSE, and encephalitis by pocEEG | All patients with impaired consciousness presenting to the PED will receive a pocEEG. We analyse the number of patients with SE, NCSE, and encephalitis diagnosed by pocEEG | Baseline | |
Primary | Agreement pocEEG vs. conventional EEG in epilepsy clinic | Agreement of pocEEG and cEEG findings in simultaneous tracings carried out during routine care in the epilepsy clinic. | Baseline |
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