Condition category
Nervous System Diseases
Date applied
03/03/2019
Date assigned
06/03/2019
Last edited
10/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Status epilepticus (SE) is a life-threatening condition in which a person has a seizure (fit) lasting more than 5 minutes or repeated seizures within 5 minutes without returning to normal in between. It can result in death or long-lasting injury to the brain. SE can occur in people with epilepsy or in people who don't have epilepsy and can have a variety of causes. SE should be treated as an emergency and requires several assessments and treatments to be given quickly. The European and American Epilepsy Societies have published guidelines for the treatment of SE to encourage consistent high-quality treatment of SE. Most national guidelines are based on these guidelines. However, the quality of SE treatment and whether the guidelines are followed by doctors has not been tested in a standardized setting. The study will simulate an emergency where a person has SE from alcohol withdrawal and will test the doctor's decisions in how to investigate, treat and follow up the patient. The aim is to measure the quality of doctors' emergency first response to SE and to identify risk factors for not following treatment guidelines.

Who can participate?
Voluntary workshops will be offered to medical doctors working as resident physicians in the following four medical fields: intensive care medicine, emergency medicine, internal medicine and neurology at the University Hospital Basel.

What does the study involve?
All participants will receive an introduction to the simulator and the simulator room and how they work. Participants will perform the simulation one by one. Participants will be informed that the scenario is that they are the physician on call on an emergency unit and that a nurse will be available to support them. The nurse will be instructed to display a helpful manner but to act on the doctor's command only.

What are the benefits and risks of participating?
There are no anticipated risks, since the participants will only be taking part in a simulated emergency. Participants might benefit from the opportunity to practice an emergency scenario.

Where is the study run from?
University Hospital Basel (Switzerland)

When is the study starting and how long is it expected to run for?
June 2016 to July 2018

Who is funding the study?
University Hospital Basel (Switzerland)

Who is the main contact?
Dr Raoul Sutter (raoul.sutter@usb.ch)


Trial website

Contact information

Type

Scientific

Primary contact

Dr Raoul Sutter

ORCID ID

http://orcid.org/0000-0002-6575-356X

Contact details

University Hospital Basel
Petersgraben 4
4031 Basel
Basel
4031
Switzerland
0041612652525
raoul.sutter@usb.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol01/2017

Study information

Scientific title

Emergency management of convulsive status epilepticus in a high-fidelity simulation: a prospective single-blinded study

Acronym

SESIM

Study hypothesis

We hypothesize that emergency response to patients with suspected status epilepticus does not strictly adhere to current international treatment guidelines.

Ethics approval

Ethics approval not required: this study is part of our quality assurance program

Study design

Prospective single-blinded observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet..

Condition

Status epilepticus

Intervention

All participating physicians will receive a standardized introduction of the technicalities of the simulator and the simulator room. Participating physicians will be asked if they would like to voluntarily be trained for clinical emergency scenarios. Upon their agreement, they will be informed that for the scenario they will be the physician on call on an emergency unit and that a nurse will be available to support them. The nurse will be instructed to display a helpful manner but to act on command only. The scenario will represent a patient admitted to the emergency room with convulsive status epilepticus induced by alcohol withdrawal.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Time to airway protection
2. Time to administration of supplementary oxygen
3. Time to administration of first- and second-line antiseizure drugs
All times are measured during simulation (i.e. time from start of simulated scenario to action/treatment).

Secondary outcome measures

1. Assessment of vital signs and neurologic status
2. Ascertainment of medical history and laboratory results
3. Performance of and time to assessment of treatment responsiveness
4. Correct aftermath reporting of clinical characteristics, management aspects, diagnosis and etiology
5. Subjective self-evaluation, including subjective stress level, quality of their performance, the performance of the nurse and certainty of diagnosis, assessed using a questionnaire
Secondary outcomes 1-4 are assessed by analyses of the audio-video recordings by two independent investigators. In cases of disagreement or discrepancies, re-analysis of the recordings are performed to reach consensus.

Overall trial start date

01/06/2016

Overall trial end date

01/07/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Volunteering medical doctors working as resident physicians in different medical fields, including intensive care medicine, emergency medicine, internal medicine, and neurology

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

50

Total final enrolment

58

Participant exclusion criteria

Physicians already having participated in the same simulated clinical scenario

Recruitment start date

01/01/2017

Recruitment end date

01/07/2018

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel

Sponsor details

Medical Intensive Care Units
Basel
4031
Switzerland
+41 61 265 25 25
stephan.marsch@usb.ch

Sponsor type

Hospital/treatment centre

Website

https://www.unispital-basel.ch/ueber-uns/bereiche/medizin/kliniken-institute-abteilungen/intensivmedizin/lehre-forschung/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish our results in a peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality issues.

Intention to publish date

01/07/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31594860 (added 10/10/2019)

Publication citations

Additional files

Editorial Notes

10/10/2019: The following changes were made: 1. Publication reference added. 2. The final enrolment number was added from the reference. 05/03/2019: Trial's existence confirmed by Ethikkommision Nordwest- und Zentralschweiz [North-west and Central Switzerland Ethics Committee].