Status:
COMPLETED
Comparison of Narcotrend and Cerebral Function Analysing Monitor in Intensive Care to Monitor Seizures and Deep Sedation
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Conditions:
Traumatic Brain Injury
Subarachnoid Hemorrhage
Eligibility:
All Genders
1+ years
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 pae...
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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- Participants will be excluded from the study where consent is not granted or withdrawn.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.
Key Trial Info
Start Date :
June 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 25 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06067750
Start Date
June 27 2023
End Date
May 25 2024
Last Update
July 14 2025
Active Locations (1)
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1
Nottingham University Hospitals Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH