Point-of-care EEG in the Pediatric Emergency Department

Status Epilepticus Clinical Trial

Official title:

The Role of Point-of-care EEG in the Pediatric Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418634
• Other study ID #: 2022-00842
• Status: Recruiting
• Start date: August 24, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2024
• Source: University Children's Hospital, Zurich
• Contact: Leopold Simma, MD
• Phone: +41442667111
• Email: leopold.simma[@]kispi.uzh.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Altered Mental Status
• Emergencies
• Non-Convulsive Status Epilepticus
• Status Epilepticus

Intervention

Other:
• point of care EEG
For pocEEG, scalp electrodes are applied in five locations.

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich	Pediatric Emergency Department, Inselspital Bern, Switzerland, Pediatric Neurology Department, Inselspital Bern, Switzerland (Dr. Sanchez-Albisua)

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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

Outcome

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