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NCT06067750
Comparison of Narcotrend and Cerebral Function Analysing Monitor in Intensive Care to Monitor Seizures and Deep Sedation
trial testing Narcotrend compared to Cerebral Function Analysing Monitor (CFAM) in Traumatic Brain Injury in 44 participants. Completed in 25 May 2024.
25 May 2024
Quick facts
| Lead sponsor | Nottingham University Hospitals NHS Trust |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 44 |
| Start date | 27 June 2023 |
| Primary completion | 25 May 2024 |
| Estimated completion | 25 May 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Narcotrend compared to Cerebral Function Analysing Monitor (CFAM)
Conditions studied
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
- Subarachnoid Hemorrhage — all drugs for Subarachnoid Hemorrhage →
- Intracerebral Haemorrhage — all drugs for Intracerebral Haemorrhage →
- Encephalitis — all drugs for Encephalitis →
Sponsor
Nottingham University Hospitals NHS Trust
Who can join
1 Month and older, any sex, with Traumatic Brain Injury or Subarachnoid Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06067750
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06067750 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nottingham University Hospitals NHS Trust
- Last refreshed: 14 July 2025
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