Comparing two monitors for detecting seizures and sedation levels in intensive care patients
The Narcotrend Depth of Anaesthesia Monitor as an Indicator of Seizures and Burst Suppression in the Intensive Care Unit
This study is testing whether a new monitor can better detect seizures and sedation levels in critically ill adults and children compared to the standard monitor currently used in intensive care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 106 (estimated) |
| Ages | 1 Month and up |
| Sex | All |
| Sponsor | Nottingham University Hospitals NHS Trust Academic / other |
| Locations | 1 site (Nottingham, Nottinghamshire) |
| Trial ID | NCT06067750 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of the Narcotrend monitor against the standard Cerebral Function Analysing Monitor (CFAM) in detecting seizures and monitoring sedation levels in both adult and pediatric patients in intensive care. The study will include patients who are at risk of seizures due to conditions such as traumatic brain injury, subarachnoid hemorrhage, and acute ischemic stroke. By utilizing non-invasive monitoring techniques, the study seeks to improve the identification of subclinical seizures that may go unnoticed in critically ill patients. The findings could help streamline monitoring processes in intensive care units, potentially reducing costs and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adult and pediatric patients in intensive care who are at risk for seizures due to various neurological conditions.
Not a fit: Patients who do not require continuous monitoring for seizures or who are not in a critical care setting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the detection of seizures in critically ill patients, leading to better management and outcomes.
How similar studies have performed: While the use of CFAM is established, the comparative effectiveness of Narcotrend in this specific context is less explored, making this study a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nottingham, Nottinghamshire
- Nottingham University Hospitals Trust — Nottingham, Nottinghamshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Helen Sneath, DClinSci-stu — Nuh
- Study coordinator: Helen Sneath, DClinSci-stu
- Email: helen.sneath@nuh.nhs.uk
- Phone: _441159249924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.