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Completed

NCT Number: NCT03883516

Improving Emergency Management of Status Epilepticus

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.

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Key information

Conditions

Status Epilepticus Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Pre-briefing with the current SE treatment guidelines

Other

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

Pre-briefing with a consolidated "one page" SE treatment guide

Other

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

No Pre-briefing

Other

no instruction of the study participants prior to the simulation training

Primary outcomes

  1. Time to SE recognition (minutes)

    Time frame: from start of simulation training until recognition of seizure and/or SE (max. 20 minutes)

    time to recognition of seizure and/or SE

Secondary outcomes

  1. administration of anti-seizure medication

    Time frame: within the first 20 minutes after beginning of the simulation training

    time of administration of anti-seizure medication (minutes)

  2. dose of anti-seizure medication

    Time frame: within the first 20 minutes after beginning of the simulation training

    dose of anti-seizure medication (mg)

  3. time to correct airways protection

    Time frame: from start of simulation training until correct airways protection (max. 20 minutes)

    time to correct airways protection (minutes)

  4. quantification of Glasgow Coma Score (GCS)

    Time frame: within the first 20 minutes after beginning of the simulation training

    GCS 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: SESIM

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2019
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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