SeizuresNCT07136298
Seizure Identification on the Intensive Care Unit (ICU)
An observational study of Seizures, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this project is to assess the ability of different groups of National Heath Service (NHS) professionals to correctly identify clinical seizures, and distinguish them from other movements commonly seen in the ICU environment, when shown digital video recordings only. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Seizures
- What is being tested?
- Clinical Opinion
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population are staff working in the Adult ICU at Nottingham University Hospitals, in one of the following groups; Neurophysiology Scientists/Clinical Physiologists, Neurophysiologists, Neurologists, Intensivists, Advanced Clinical Practitioners and Nursing Staff
Who may be able to join
- Staff working at Nottingham University Hospitals (NUH) in one of the following staff groups;
- Neurophysiology Scientists/Clinical Physiologists at Band 7 level and above,
- Neurophysiologists who have completed the CCT in Neurophysiology with at least 1 year of Adult ICU experience.
- members of the Neurology medical team with at least 1 years' experience of covering ITU
- Intensivists with at least 1 year's experience working on the Adult intensive care unit
- Nursing staff working on the Intensive care unit with at least 1 year's experience
Who cannot join
- Staff not employed by NUH i.e. agency staff
- Staff in other groups not mentioned above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospitals
Nottingham, Nottinghamshire, NG7 2UH
James S Baird, 0115 9709146, james.baird@nhs.net
About this study
Official title: Seizure Semiology Identification and Agreement in the Intensive Care Setting: How do Clinical Scientists Compare to Other Healthcare Professionals (Intensivists, Neurologists, ITU Nurses and Neurophysiologists) in Identifying and Interpreting Clinical Signs in Patients on the Adult Intensive Care Unit
The aim of this project is to assess the ability of different groups of National Heath Service (NHS) professionals to correctly identify clinical seizures, and distinguish them from other movements commonly seen in the ICU environment, when shown digital video recordings only.
Patients on the ICU are at risk of having seizures, however also commonly make other movements, including shivering, jerking, tics and tremors. An Electroencephalogram (EEG) records the brain wave activity and can help distinguish epileptic seizures from other movements. In a study by Bendadis et al (2010), 52 video-EEGs were reviewed containing "possible seizures" on the ICU. They found only 27% recorded actual epileptic events, with the other 73% having a range of other movements. Malone et al (2009) studied accuracy of diagnosis of 20 video recordings of clinical episodes on the neonatal unit, comparing different staff groups. They found no significant difference between Doctors and Nurses in correctly identifying seizures, however found that accuracy of diagnosis was generally poor.
Read more
Clinical scientists are currently expanding their roles and responsibilities across Neurophysiology, including giving consultant-level advice on EEG investigations. EEG recordings on the ICU are often obscured by excessive, unavoidable electrical/movement artefacts caused by equipment such ventilators and pumps, and patient factors such as position, breathing artefact and suctioning. These make the EEG difficult to interpret (Boggs 2021). Assessing the clinical signs and symptoms which we may see in ICU patients, in the absence of interpretable EEG, is an essential skill.
This study aims to assess Clinical Scientists skills at clinical interpretation, in comparison with other staff groups in the ICU setting. Staff will be asked to watch video clips of events captured in the ICU, and tell us whether they think they are seizures or not, and explain their thought process behind the decision.
- Conditions
- Seizures
- Being tested
- Clinical Opinion
- Keywords
- Intensive Care, Clinical Scientist, Neurologists, Intensivists, ITU Nurses
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical OpinionOther
Staff participants will be asked to review video clips of events captured during EEGs performed on the ICU and asked to state whether they think the event was an epileptic seizure or not, and what aspects of each event led them to that decision
| Study group | Role | What they receive |
|---|---|---|
| Clinical Scientists | Not described Receives: Other: Clinical Opinion | |
| Advanced Clinical Practitioners | Not described Receives: Other: Clinical Opinion | |
| Intensivists | Not described Receives: Other: Clinical Opinion | |
| Clinical Neurophysiologists | Not described Receives: Other: Clinical Opinion | |
| Neurologists | Not described Receives: Other: Clinical Opinion | |
| ICU Nurses | Not described Receives: Other: Clinical Opinion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Agreement
The primary outcome measure is the level of agreement between the clinical opinion of the different staff groups and the EEG result
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Interrater Reliability
The level of agreement between the different individuals in each staff group.
Measured: through study completion, an average of 1 year
Thematic Analysis
thematic analysis of the decision making process (based on the free text justifications for why individuals made the choice they did)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start3 Mar 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136298
- Sponsor's protocol ID
- 24CN001
- Status last verified
- Aug 2025
- First submitted
- 18 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seizure Semiology Identification and Agreement in the Intensive Care Setting: How do Clinical Scientists Compare to Other Healthcare Professionals (Intensivists, Neurologists, ITU Nurses and Neurophysiologists) in Identifying and Interpreting Clinical Signs in Patients on the Adult Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07136298
- Acronym / sponsor ID
- 24CN001
- Conditions
- Seizures
- Keywords
- Intensive Care, Clinical Scientist, Neurologists, Intensivists, ITU Nurses
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 22 Aug 2025 (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.
The aim of this project is to assess the ability of different groups of National Heath Service (NHS) professionals to correctly identify clinical seizures, and distinguish them from other movements commonly seen in the ICU environment, when shown digital video recordings only.
Patients on the ICU are at risk of having seizures, however also commonly make other movements, including shivering, jerking, tics and tremors. An Electroencephalogram (EEG) records the brain wave activity and can help distinguish epileptic seizures from other movements. In a study by Bendadis et al (2010), 52 video-EEGs were reviewed containing "possible seizures" on the ICU. They found only 27% recorded actual epileptic events, with the other 73% having a range of other movements. Malone et al (2009) studied accuracy of diagnosis of 20 video recordings of clinical episodes on the neonatal unit, comparing different staff groups. They found no significant difference between Doctors and Nurses in correctly identifying seizures, however found that accuracy of diagnosis was generally poor.
Clinical scientists are currently expanding their roles and responsibilities across Neurophysiology, including giving consultant-level advice on EEG investigations. EEG recordings on the ICU are often obscured by excessive, unavoidable electrical/movement artefacts caused by equipment such ventilators and pumps, and patient factors such as position, breathing artefact and suctioning. These make the EEG difficult to interpret (Boggs 2021). Assessing the clinical signs and symptoms which we may see in ICU patients, in the absence of interpretable EEG, is an essential skill.
This study aims to assess Clinical Scientists skills at clinical interpretation, in comparison with other staff groups in the ICU setting. Staff will be asked to watch video clips of events captured in the ICU, and tell us whether they think they are seizures or not, and explain their thought process behind the decision.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Clinical Scientists | – | Other: Clinical Opinion |
| Advanced Clinical Practitioners | – | Other: Clinical Opinion |
| Intensivists | – | Other: Clinical Opinion |
| Clinical Neurophysiologists | – | Other: Clinical Opinion |
| Neurologists | – | Other: Clinical Opinion |
| ICU Nurses | – | Other: Clinical Opinion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are staff working in the Adult ICU at Nottingham University Hospitals, in one of the following groups; Neurophysiology Scientists/Clinical Physiologists, Neurophysiologists, Neurologists, Intensivists, Advanced Clinical Practitioners and Nursing Staff
Key inclusion criteria (6 listed)
- Staff working at Nottingham University Hospitals (NUH) in one of the following staff groups;
- Neurophysiology Scientists/Clinical Physiologists at Band 7 level and above,
- Neurophysiologists who have completed the CCT in Neurophysiology with at least 1 year of Adult ICU experience.
- members of the Neurology medical team with at least 1 years' experience of covering ITU
- Intensivists with at least 1 year's experience working on the Adult intensive care unit
Key exclusion criteria (2 listed)
- Staff not employed by NUH i.e. agency staff
- Staff in other groups not mentioned above
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 |
|---|---|---|
| Clinical OpinionStaff participants will be asked to review video clips of events captured during EEGs performed on the ICU and asked to state whether they think the event was an epileptic seizure or not, and what aspects of each event led them to that decision | Other | Advanced Clinical Practitioners, Clinical Neurophysiologists, Clinical Scientists, ICU Nurses, Intensivists, Neurologists |
Primary outcome
Level of Agreement
Time frame: through study completion, an average of 1 year
The primary outcome measure is the level of agreement between the clinical opinion of the different staff groups and the EEG result
2 secondary outcomes
Interrater Reliability
Time frame: through study completion, an average of 1 year
Thematic Analysis
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Aug 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 United Kingdom. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James S Baird (01159709146, james.baird@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Agreement (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.