NCT06067750

Comparison of Narcotrend and Cerebral Function Analysing Monitor in Intensive Care to Monitor Seizures and Deep Sedation

The Narcotrend Depth of Anaesthesia Monitor as an Indicator of Seizures and Burst Suppression in the Intensive Care Unit

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Traumatic Brain Injury
• Subarachnoid Hemorrhage
• Intracerebral Haemorrhage
• Encephalitis
• Acute Ischemic Stroke
• Status Epilepticus
• Seizures
• Subdural Hematoma
• ICP (Intracranial Pressure) Increase

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Narcotrend compared to Cerebral Function Analysing Monitor (CFAM)	All patients will receive Narcotrend and CFAM monitoring in this observational study

Timeline

• Start date: 2023-06-27
• Primary completion: 2024-05-25
• Completion: 2024-05-25
• First posted: 2023-10-05
• Last updated: 2025-07-14

Locations

1 site across 1 country: United Kingdom