An observational study in Traumatic Brain Injury, Subarachnoid Hemorrhage and Intracerebral Haemorrhage, sponsored by Nottingham University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 1 Month and older. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Nottingham University Hospitals NHS Trust · Observational
A study in the use of the Narcotrend depth of anaesthesia monitor to record a) seizures, and b) monitor a level of sedation referred to as 'burst suppression', in sedated patients in the adult and paediatric intensive care.
Studies have shown that patients in coma on the intensive care unit may have subclinical in addition to clinical seizures. Subclinical seizures are seizures that do not show any outward signs and may go undetected.
The current gold standard of recording seizures in the intensive care unit is by non-invasive, continuous monitoring of the electrical activity of the brain by electroencephalography (cEEG) using cerebral function analysing monitor (CFAM).
This is recorded with simultaneous video recording and is performed by Clinical Neurophysiology departments.
There has been a steady increase in demand for this service over recent years. Additionally, CFAM / cEEG is labour intensive and expensive. If trends continue, the proportion of hospitals offering CFAM / cEEG will continue to rise, creating increased demand for specialist staff, of which there are a finite number.
Depth of anaesthesia monitors are used by anaesthetists to assess the level of anaesthesia in sedated patients using specialised, automated EEG analysis and are now recommended by NICE (DG6) to tailor anaesthetic dose to individual patients.
This study aims to investigate the utility of the Narcotrend depth of anaesthesia monitor to monitor for seizures and burst suppression on the adult and paediatric intensive care unit. These monitors are cheaper and more widely available with the scope to be used at every bed space requiring neuro observation on the intensive care unit.
The study aims to recruit all patients who are referred for CFAM / cEEG monitoring at Nottingham University Hospitals (NUH) Trust over a 12 month period. These patients will undergo simultaneous recording using CFAM / cEEG and depth of anaesthesia monitoring.
A non-invasive, prospective, observational, qualitative, comparative study performed on the adult and paediatric intensive care unit of NUH Trust. Study population will be all adult and paediatric patients referred for CFAM monitoring, including, but not limited to patients who are at risk of seizures due to status epilepticus, haemorrhage and traumatic brain injury.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's enrollment of 44 is below the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Nottingham University Hospitals NHS Trust is the lead sponsor of 107 studies on the registry; 19 are open to participants now.
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Study population will be all adult and paediatric patients referred for CFAM monitoring, including, but not limited to patients who are at risk of seizures due to status epilepticus, haemorrhage and traumatic brain injury.
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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:
Exclusion Criteria:
Patients referred from both adult and paediatric intensive care units
Diagnostic Test: Narcotrend compared to Cerebral Function Analysing Monitor (CFAM)
All patients will receive Narcotrend and CFAM monitoring in this observational study
Seizure detection
The number of seizures detected and verified by the Narcotrend monitor when compared to the number of seizures detected by conventional CFAM / cEEG monitoring. Seizure activity is detected by analysing changes in brain activity. This is done by visually analysing waveforms
Time frame: Up to 72 hours monitoring of each patient
Burst suppression monitoring
The number of periods of burst suppression detected and verified by the Narcotrend monitor when compared and detected by conventional CFAM / cEEG monitoring. Burst suppression is detected by analysing changes in brain activity. This is done by visually analysing waveforms
Time frame: Up to 72 hours monitoring of each patient
Interrater reliability
Compare the interrater reliability between clinical neurophysiology staff and the non-expert reviewers (intensivists / advanced critical care practitioners) in assessing seizures and periods of burst suppression activity using CFAM and Narcotrend equipment. The non-expert group will categorise the Narcotrend and CFAM recordings blindly and retrospectively. Their findings will then be compared to clinical neurophysiology findings for the same machines and categories to compare interrater agreement.
Time frame: Up to 72 hours monitoring of each patient
Plan to share: No
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Nottingham University Hospitals NHS Trust →