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

NCT06067750 | Completed

• 1 other identifier: 21IT001
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to 72 hours monitoring of each patient

Secondary Outcomes (1)

• Interrater reliability

  Up to 72 hours monitoring of each patient

Study Arms (1)

Patients referred to Clinical Neurophysiology for Cerebral Function Analysing Monitoring (CFAM)

Patients referred from both adult and paediatric intensive care units

Diagnostic Test: Narcotrend compared to Cerebral Function Analysing Monitor (CFAM)

Interventions

Narcotrend compared to Cerebral Function Analysing Monitor (CFAM) DIAGNOSTIC_TEST

All patients will receive Narcotrend and CFAM monitoring in this observational study

Patients referred to Clinical Neurophysiology for Cerebral Function Analysing Monitoring (CFAM)

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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:
• Persistently abnormal mental status following generalised convulsive status epilepticus (GCSE) or other clinically evident seizures.
• 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.
• 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.
• Patients requiring pharmacological paralysis and risk for seizures.
• Clinical paroxysmal events suspected to be seizures, to determine whether they are ictal or non-ictal
• Patients with suggested secondary brain injury e.g. those with increased intracranial pressure.
• Monitoring of the response of seizures and status epilepticus to treatment and to a level of burst suppression

You may not qualify if:

• 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.
• 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.
• 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.
• Data gained from patients who regain capacity to give retrospective consent and then withdraw will also be excluded.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (7)

• Bader MK, Arbour R, Palmer S. Refractory increased intracranial pressure in severe traumatic brain injury: barbiturate coma and bispectral index monitoring. AACN Clin Issues. 2005 Oct-Dec;16(4):526-41. doi: 10.1097/00044067-200510000-00009.

  PMID: 16269897 BACKGROUND

• Arbour RB, Dissin J. Predictive value of the bispectral index for burst suppression on diagnostic electroencephalogram during drug-induced coma. J Neurosci Nurs. 2015 Apr;47(2):113-22. doi: 10.1097/JNN.0000000000000124.

  PMID: 25629593 BACKGROUND

• Berger-Estilita J, Steck K, Vetter C, Seidel K, Krejci V, Hight D, Kaiser H. A case report of several intraoperative convulsions while using the Narcotrend monitor: Significance and predictive use. Medicine (Baltimore). 2019 Nov;98(47):e18004. doi: 10.1097/MD.0000000000018004.

  PMID: 31764814 BACKGROUND

• Dahaba AA, Liu DW, Metzler H. Bispectral index (BIS) monitoring of acute encephalitis with refractory, repetitive partial seizures (AERRPS). Minerva Anestesiol. 2010 Apr;76(4):298-301.

  PMID: 20332745 BACKGROUND

• Dwivedi D, Bhatnagar V, Kiran S, Ray A. Intraoperative seizures during redo cranioplasty for sinking skin flap syndrome- Role of BIS monitor in detection. Saudi J Anaesth. 2017 Jul-Sep;11(3):359-360. doi: 10.4103/sja.SJA_44_17. No abstract available.

  PMID: 28757846 BACKGROUND

• Iturri Clavero F, Tamayo Medel G, de Orte Sancho K, Gonzalez Uriarte A, Iglesias Martinez A, Martinez Ruiz A. Use of BIS VISTA bilateral monitor for diagnosis of intraoperative seizures, a case report. Rev Esp Anestesiol Reanim. 2015 Dec;62(10):590-5. doi: 10.1016/j.redar.2015.03.006. Epub 2015 May 3.

  PMID: 25944463 BACKGROUND

• Tallach RE, Ball DR, Jefferson P. Monitoring seizures with the Bispectral index. Anaesthesia. 2004 Oct;59(10):1033-4. doi: 10.1111/j.1365-2044.2004.03953.x. No abstract available.

  PMID: 15488073 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Encephalitis; Ischemic Stroke; Status Epilepticus; Seizures; Hematoma, Subdural; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Stroke; Neurologic Manifestations; Signs and Symptoms; Intracranial Hemorrhage, Traumatic; Hematoma

Study Officials

• Helen Sneath, DClinSci-stu

  NUH

  PRINCIPAL INVESTIGATOR

• Ziad Alrifai, MBChB(Hons)

  Nottingham University Hospitals Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: October 5, 2023
• Study Start: June 27, 2023
• Primary Completion: May 25, 2024
• Study Completion: May 25, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)