Improving Emergency Management of Status Epilepticus

NCT ID: NCT03883516

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2024-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Status Epilepticus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No pre-briefing prior to the simulation training

No pre-briefing prior to the simulation training

Group Type PLACEBO_COMPARATOR

No Pre-briefing

Intervention Type OTHER

no instruction of the study participants prior to the simulation training

Pre-briefing with the current SE treatment guidelines

pre-briefing with the current SE treatment Guidelines published by the American Epilepsy Society

Group Type ACTIVE_COMPARATOR

Pre-briefing with the current SE treatment guidelines

Intervention Type 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 consolidated SE treatment guideline

pre-briefing with the consolidated "one page" SE treatment guideline

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pre-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

Intervention Type OTHER

Pre-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

Intervention Type OTHER

No Pre-briefing

no instruction of the study participants prior to the simulation training

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raoul Sutter, PD Dr. MD

Role: PRINCIPAL_INVESTIGATOR

Clinic for Intensive Care Medicine, University Hospital Basel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Requ_2019-00168; me19Sutter3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ESIS in Pediatric DRE
NCT05469373 RECRUITING