Status EpilepticusSESIMNCT03883516
Improving Emergency Management of Status Epilepticus
A study testing Pre-briefing with the current SE treatment guidelines, Pre-briefing with a consolidated "one page" SE treatment guide and No Pre-briefing in people with Status Epilepticus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Pre-briefing with the current SE treatment guidelines, Pre-briefing with a consolidated "one page" SE treatment guide and No Pre-briefing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2020to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Physicians from different medical specialties working at the University Hospital Basel
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Intensive Care Medicine, University Hospital Basel
Basel, 4031
About this study
Official title: Improving Emergency Management of Status Epilepticus - a High-fidelity Simulator-based Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Status Epilepticus
- Being tested
- Pre-briefing with the current SE treatment guidelines, Pre-briefing with a consolidated "one page" SE treatment guide, No Pre-briefing
- Keywords
- guideline for the treatment of Status Epilepticus, antiseizure drugs (ASDs)
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-briefing with the current SE treatment guidelinesOther
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 guideOther
instruction of the study participants with a consolidated "one page" SE treatment guide prior to the simulation training
No Pre-briefingOther
no instruction of the study participants prior to the simulation training
| Study group | Role | What they receive |
|---|---|---|
| No pre-briefing prior to the simulation training | Placebo comparator | No pre-briefing prior to the simulation training Receives: 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 Receives: 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 Receives: Other: Pre-briefing with a consolidated "one page" SE treatment guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to SE recognition (minutes)
time to recognition of seizure and/or SE
Measured: from start of simulation training until recognition of seizure and/or SE (max. 20 minutes)
Secondary outcomes (4)
administration of anti-seizure medication
time of administration of anti-seizure medication (minutes)
Measured: within the first 20 minutes after beginning of the simulation training
dose of anti-seizure medication
dose of anti-seizure medication (mg)
Measured: within the first 20 minutes after beginning of the simulation training
time to correct airways protection
time to correct airways protection (minutes)
Measured: from start of simulation training until correct airways protection (max. 20 minutes)
quantification of Glasgow Coma Score (GCS)
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).
Measured: within the first 20 minutes after beginning of the simulation training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Dec 2020
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, PD Dr. MD, Principal investigator, Clinic for Intensive Care Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883516
- Sponsor's protocol ID
- Requ_2019-00168; me19Sutter3
- Acronym
- SESIM
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2019
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kliem PSC, Tisljar K, Baumann SM, Grzonka P, De Marchis GM, Bassetti S, Bingisser R, Hunziker S, Marsch S, Sutter R. Improving emergency management of status epilepticus: a randomized high-fidelity simulator-based trial. J Neurol. 2026 Aug 19;273(9):533. doi: 10.1007/s00415-026-14058-8.
PubMed 42618689
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Emergency Management of Status Epilepticus - a High-fidelity Simulator-based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03883516
- Acronym / sponsor ID
- SESIM / Requ_2019-00168; me19Sutter3
- Conditions
- Status Epilepticus
- Keywords
- guideline for the treatment of Status Epilepticus, antiseizure drugs (ASDs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No pre-briefing prior to the simulation training | Placebo comparator | Other: No Pre-briefingNo pre-briefing prior to the simulation training |
| Pre-briefing with the current SE treatment guidelines | Active comparator | Other: Pre-briefing with the current SE treatment guidelinespre-briefing with the current SE treatment Guidelines published by the American Epilepsy Society |
| pre- briefing with consolidated SE treatment guideline | Active comparator | Other: Pre-briefing with a consolidated "one page" SE treatment guidepre-briefing with the consolidated "one page" SE treatment guideline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians from different medical specialties working at the University Hospital Basel
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-briefing with the current SE treatment guidelinesinstruction 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 | Other | Pre-briefing with the current SE treatment guidelines |
| Pre-briefing with a consolidated "one page" SE treatment guideinstruction of the study participants with a consolidated "one page" SE treatment guide prior to the simulation training | Other | pre- briefing with consolidated SE treatment guideline |
| No Pre-briefingno instruction of the study participants prior to the simulation training | Other | No pre-briefing prior to the simulation training |
Primary outcome
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
4 secondary outcomes
administration of anti-seizure medication
Time frame: within the first 20 minutes after beginning of the simulation training
dose of anti-seizure medication
Time frame: within the first 20 minutes after beginning of the simulation training
time to correct airways protection
Time frame: from start of simulation training until correct airways protection (max. 20 minutes)
quantification of Glasgow Coma Score (GCS)
Time frame: within the first 20 minutes after beginning of the simulation training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 42618689Kliem PSC, Tisljar K, Baumann SM, Grzonka P, De Marchis GM, Bassetti S, Bingisser R, Hunziker S, Marsch S, Sutter R. Improving emergency management of status epilepticus: a randomized high-fidelity simulator-based trial. J Neurol. 2026 Aug 19;273(9):533. doi: 10.1007/s00415-026-14058-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Sutter, PD Dr. MD principal investigator
Clinic for Intensive Care Medicine, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-briefing with the current SE treatment guidelines, Pre-briefing with a consolidated "one page" SE treatment guide and No Pre-briefing in people with Status Epilepticus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to SE recognition (minutes) (time frame: from start of simulation training until recognition of seizure and/or SE (max. 20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03883516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.