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Search / Trial NCT06067750

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

Narcotrend Continuous Electroencephalography Cerebral Function Analysing Monitor Depth Of Anaesthesia Monitor Seizures Burst Suppression Intensive Care

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.

Locations

Nottingham, Nottinghamshire, United Kingdom

Patients applied

0 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