Comparison of Narcotrend and Cerebral Function Analysing Monitor in Intensive Care to Monitor Seizures and Deep Sedation
Launched by NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST · Oct 2, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a device called the Narcotrend monitor, which helps doctors track brain activity to identify seizures and measure sedation levels in patients who are very ill and may be in a coma. The goal is to see if this monitor can be a more accessible and cost-effective way to detect seizures compared to the current standard method, which uses more complex equipment called cEEG. This study is particularly important because some seizures do not show visible signs and can go unnoticed, potentially affecting patient care.
Eligible participants include adults and children in the intensive care unit who have certain serious conditions, like traumatic brain injury or severe brain swelling, and are at risk of having seizures. If enrolled in the study, patients will have their brain activity monitored using both the Narcotrend and the standard cEEG method for comparison. This trial is currently recruiting participants at Nottingham University Hospitals, and next of kin will be approached for consent when appropriate. The findings from this study could help improve monitoring practices for critically ill patients, making it easier to manage their care.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- Intensive care CFAM is recommended but not confined to identify non-convulsive seizures and non-convulsive status epilepticus (NCSE) in critically ill patients with the following:
- • 1. Persistently abnormal mental status following generalised convulsive status epilepticus (GCSE) or other clinically evident seizures.
- • 2. Acute supratentorial brain injury with altered mental status. This includes traumatic brain injury, subarachnoid hemorrhage, intracerebral hemorrhage, encephalitis, acute ischemic stroke, and during and after therapeutic hypothermia following cardiac arrest.
- • 3. Fluctuating mental status or unexplained alteration of mental status without known acute brain injury: Mental status abnormalities can include agitation, lethargy, fixed or fluctuating neurologic deficits such as aphasia or neglect, obtundation, and coma.
- • 4. Patients requiring pharmacological paralysis and risk for seizures.
- • 5. Clinical paroxysmal events suspected to be seizures, to determine whether they are ictal or non-ictal
- • 6. Patients with suggested secondary brain injury e.g. those with increased intracranial pressure.
- • 7. Monitoring of the response of seizures and status epilepticus to treatment and to a level of burst suppression
- Exclusion Criteria:
- • 1. Patients where CFAM has been requested but a routine EEG is thought to be more appropriate, eg. in cases where a routine 20 minute EEG would answer the clinical / referral question.
- • 2. Next of kin will not be approached to consent for the patient to be enrolled into the study where clinical condition dictates that it would not be appropriate eg. imminent withdrawal of care.
- • 3. Participants will be excluded from the study where consent is not granted or withdrawn. This may be at commencement of the study by parents of paediatric patients or next of kin of adult patients.
- • 4. Data gained from patients who regain capacity to give retrospective consent and then withdraw will also be excluded.
About Nottingham University Hospitals Nhs Trust
Nottingham University Hospitals NHS Trust is a leading healthcare provider in the UK, dedicated to delivering high-quality patient care and advancing medical research. Comprising two major hospitals, Queen's Medical Centre and Nottingham City Hospital, the Trust is at the forefront of clinical innovation and education. With a strong emphasis on translational research, Nottingham University Hospitals NHS Trust actively sponsors clinical trials aimed at improving treatment outcomes and understanding various health conditions. The Trust collaborates with academic institutions, healthcare professionals, and industry partners to foster a robust research environment that enhances clinical practice and contributes to evidence-based medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nottingham, Nottinghamshire, United Kingdom
Patients applied
Trial Officials
Helen Sneath, DClinSci-stu
Principal Investigator
NUH
Ziad Alrifai, MBChB(Hons)
Study Director
Nottingham University Hospitals Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported