Status epilepticus Nervous System Diseases Status epilepticus
Conditions
Interventions
The intervention comprises administration of 5% carbogen by spontaneous inhalation administered via a loosely attached face mask (flow rate 5l/min) for a period stipulated by the protocol (timed by ha
Sponsors
Newcastle Hospitals Foundation NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Child under 16 with known epilepsy (i.e. established tendency to recurrent seizures) 2. Aetiology of epilepsy known, or investigation deemed sufficient to infer a cryptogenic (presumed symptomatic) epilepsy 3. No clinical suspicion of current episode being associated with acutely raised intracranial pressure 4. Confirmed non-convulsive status epilepticus on EEG defined as the presence of 4.1. Bihemispheric 4.2. Continuous or near-continuous 4.3. Spikewave or other features indicative of seizure activity 4.4. History from parent, or other experienced carer familiar with the patient, of lower level of awareness than normal 5. Note that the presence of subtle continuing clinical seizure activity is not an exclusion criterion so long as the treating physician is satisfied that urgent treatment is not required. 6. Informed consent provided by parent/legal guardian
Exclusion criteria
Exclusion criteria: 1. Age > 16 years 2. Absence of informed consent from parent/legal guardian 3. Evidence of prior chronic respiratory disease and/or type 2 respiratory failure as indicated by a baseline (pre-inhalation) capillary blood gas pCO2 > 8kPa 4. Any clinical suspicion of a condition associated with acutely raised intracranial pressure 5. Currently involved in any other clinical trial of an investigative medical product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Four five-minute epochs of EEG will be excerpted for each patient. 5 mins prior to inhalation and 0-5, 5-10 and 10-15 minutes after completion of inhalation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of safety 2. Capillary blood gas pH Measured at the end of the period of inhalation | — |
Countries
United Kingdom
Outcome results
None listed