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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
- Nottingham University Hospitals Trust
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients referred to Clinical Neurophysiology for Cerebral Function Analysing Monitoring (CFAM)
Patients referred from both adult and paediatric intensive care units
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All patients will receive Narcotrend and CFAM monitoring in this observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Seizure detection
Time Frame: Up to 72 hours monitoring of each patient
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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
Time Frame: Up to 72 hours monitoring of each patient
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interrater reliability
Time Frame: Up to 72 hours monitoring of each patient
|
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. |
Up to 72 hours monitoring of each patient
|
Collaborators and Investigators
Investigators
- Principal Investigator: Helen Sneath, DClinSci-stu, NUH
- Study Director: Ziad Alrifai, MBChB(Hons), Nottingham University Hospitals Trust
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neuroinflammatory Diseases
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Pathologic Processes
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Stroke
- Intracranial Hemorrhage, Traumatic
- Ischemic Stroke
- Brain Injuries
- Encephalitis
- Seizures
- Hemorrhage
- Cerebral Hemorrhage
- Hematoma, Subdural
- Hematoma
- Subarachnoid Hemorrhage
- Intracranial Hypertension
- Status Epilepticus
Other Study ID Numbers
- 21IT001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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