Skip to content

Improving Emergency Management of Status Epilepticus

Improving Emergency Management of Status Epilepticus - a High-fidelity Simulator-based Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03883516
Acronym
SESIM
Enrollment
124
Registered
2019-03-21
Start date
2020-12-01
Completion date
2024-07-15
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Status Epilepticus

Keywords

guideline for the treatment of Status Epilepticus, antiseizure drugs (ASDs)

Brief summary

In the trial the effectiveness of pre-briefing physicians with the current guideline on Status epilepticus (SE) treatment or a consolidated one page guideline regarding quality enhancement of the physician's clinical performances is investigated.

Detailed description

Status epilepticus (SE) is a life-threatening neurological emergency defined as a state of continuous seizure or multiple seizures without full recovery of sensory, motor and/or cognitive function for at least 30 minutes. To achieve high quality management of SE, the American Epilepsy Society published an evidence-based guideline for the treatment of SE, which serves as reference for most national guidelines, but analyses regarding practicability, strict adherence, correct translation into clinical practice, and identification of recommended treatment steps at risk of being modified or missed are lacking. Simulator-based studies offer a platform for the design of standardized clinical scenarios that enable detailed investigations regarding the effect of the implementation and practicability of treatment guidelines. This randomized controlled intervention study performed at the simulation center of the medical intensive care units (ICUs) at the University Hospital Basel is to investigate the effectiveness of pre-briefing physicians with both the current guideline on Status epilepticus (SE) treatment or a consolidated one page guideline regarding quality enhancement of the physicians' clinical performances.. Physicians from different medical specialties and with different duration of clinical experience will be enrolled. Participants will be randomly assigned to one of the following three pre-briefing groups: (1) no pre-briefing prior to the simulation training; (2) pre-briefing with the current SE treatment guidelines; (3) pre-briefing with the consolidated one page SE treatment guideline.

Interventions

OTHERPre-briefing with the current SE treatment guidelines

instruction of the study participants according to the evidence-based guideline for the treatment of SE published by the American Epilepsy Society prior to the simulation training

OTHERPre-briefing with a consolidated one page SE treatment guide

instruction of the study participants with a consolidated one page SE treatment guide prior to the simulation training

OTHERNo Pre-briefing

no instruction of the study participants prior to the simulation training

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Physicians from different medical specialties working at the University Hospital Basel

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Time to SE recognition (minutes)from start of simulation training until recognition of seizure and/or SE (max. 20 minutes)time to recognition of seizure and/or SE

Secondary

MeasureTime frameDescription
administration of anti-seizure medicationwithin the first 20 minutes after beginning of the simulation trainingtime of administration of anti-seizure medication (minutes)
dose of anti-seizure medicationwithin the first 20 minutes after beginning of the simulation trainingdose of anti-seizure medication (mg)
time to correct airways protectionfrom start of simulation training until correct airways protection (max. 20 minutes)time to correct airways protection (minutes)
quantification of Glasgow Coma Score (GCS)within the first 20 minutes after beginning of the simulation trainingGCS is a neurological scale recording the state of a person's consciousness ; The scale is composed of three tests: eye, verbal and motor responses. The three values separately as well as their sum are considered. The lowest possible GCS (graded 1 in each element) is 3 (deep coma or death), while the highest is 15 (fully awake person).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026