Improving Emergency Management of Status Epilepticus

NCT03883516 | Completed

• 1 other identifier: Requ_2019-00168; me19Sutter3
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Status Epilepticus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to SE recognition (minutes)

  time to recognition of seizure and/or SE

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

Secondary Outcomes (4)

• administration of anti-seizure medication

  within the first 20 minutes after beginning of the simulation training

• dose of anti-seizure medication

  within the first 20 minutes after beginning of the simulation training

• time to correct airways protection

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

• quantification of Glasgow Coma Score (GCS)

  within the first 20 minutes after beginning of the simulation training

Study Arms (3)

No pre-briefing prior to the simulation training

PLACEBO COMPARATOR

No pre-briefing prior to the simulation training

Other: No Pre-briefing

Pre-briefing with the current SE treatment guidelines

ACTIVE COMPARATOR

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

Other: Pre-briefing with the current SE treatment guidelines

pre- briefing with consolidated SE treatment guideline

ACTIVE COMPARATOR

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

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

Interventions

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 the current SE treatment guidelines

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

pre- briefing with consolidated SE treatment guideline

No Pre-briefing OTHER

no instruction of the study participants prior to the simulation training

No pre-briefing prior to the simulation training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

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

Study Officials

• Raoul Sutter, PD Dr. MD

  Clinic for Intensive Care Medicine, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 21, 2019
• Study Start: December 1, 2020
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

CH (1)