Clinical trial NCT05418634: Point-of-care EEG in the Pediatric Emergency Department
Official title: The Role of Point-of-care EEG in the Pediatric Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Status Epilepticus
Non-Convulsive Status Epilepticus
Altered Mental Status
Keywords: pediatric emergency medicine
pediatric neurology
status epliepticus
non-convulsive status epilepticus
altered mental status
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: Pediatric Neurology Department, Inselspital Bern, Switzerland (Dr. Sanchez-Albisua)
First posted: 2022-06-14
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients presenting to the PED or the epilepsy clinic fulfilling the inclusion criteria.

Brief summary: 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.

Detailed description: Non-traumatic, acute central nervous system (CNS) disorders are amongst the most frequent emergencies in childhood. In Switzerland, CNS disorders are the top ranking presentation of critically ill children. Many pediatric neurological emergencies such as coma, acute encephalopathies with impaired consciousness or agitation, or acute focal deficits, are associated with changes of cortical electrical activity detectable by the electroencephalogram (EEG). Of particular concern are status epilepticus (SE) and non-convulsive status epilepticus (NCSE). Previous studies have shown that an EEG can yield important diagnostic information and aid in decision-making. However, conventional EEG-recordings are resource intensive (time, staff), and hardly available outside of regular working hours. Point-of-care EEG (pocEEG) has proven helpful for evaluating impaired consciousness, detecting NCSE, and monitoring therapy in ongoing SE. In a retrospective cohort study from Japan patients with impaired consciousness were diagnosed with non-convulsive seizures in pocEEG, supporting the view that pocEEG can be applied by ED physicians, even in the absence of a neurologist, and can aid the detection and treatment of non-convulsive seizures. Another study, also from Japan, reported that abnormalities were detected in 20% of patients by using pocEEG in an ED setting. The aims of this study are:

* To prospectively assess the feasibility and utility of pocEEG for NCSE detection in children presenting with impaired consciousness in the PED
* To evaluate the interpretation accuracy of pocEEG by pediatric emergency medicine (PEM) providers after a teaching module.
* To compare pocEEG to the "gold standard" of simultaneously recorded conventional EEG in patients undergoing routine cEEG in the epilepsy outpatient clinics.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants diagnosed with SE, NCSE, and encephalitis by pocEEG
timeFrame: Baseline
measure: Agreement pocEEG vs. conventional EEG in epilepsy clinic
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Georgia Ramantani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.