Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT06067750
Eligibility Criteria:
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:
1. Persistently abnormal mental status following generalised convulsive status epilepticus (GCSE) or other clinically evident seizures.
2. 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.
3. 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.
4. Patients requiring pharmacological paralysis and risk for seizures.
5. Clinical paroxysmal events suspected to be seizures, to determine whether they are ictal or non-ictal
6. Patients with suggested secondary brain injury e.g. those with increased intracranial pressure.
7. Monitoring of the response of seizures and status epilepticus to treatment and to a level of burst suppression
Exclusion Criteria:
1. 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.
2. 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.
3. Participants will be excluded from the study where consent is not granted or withdrawn.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.
4. Data gained from patients who regain capacity to give retrospective consent and then withdraw will also be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Study:
NCT06067750
Study Brief:
Protocol Section:
NCT06067750