Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
This research study is evaluating a new test which may help diagnose certain types of stroke. The new test is a non invasive device (called ‘Cerebrotech Visor System’) which measures changes in brain
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Transportation to the study hospital by ambulance 3. New stroke suspected by ambulance personnel before hospital arrival 4. At least responsive to tactile stimuli (i.e. A, V or P on the AVPU scale) on hospital arrival 5. Within 6 hours of last known well time or symptom onset time (hospital specialist judgement) 6. Brain imaging is intended to be or has been conducted within 60 minutes of hospital arrival 7. A CBA reading can be attempted +/- 30 minutes of the first brain imaging 8. The CBA reading will be within 6 hours of a hospital stroke specialist last known well time or symptom onset time
Exclusion criteria
Exclusion criteria: 1. Already assessed at another hospital and transfer to the regional neurosciences centre is for further investigation or treatment 2. Hypoglycaemia (capillary glucose < 3.5 mmol/l) 3. Presence of any known implanted electro-stimulating devices in the head and neck 4. Presence of any known metallic craniofacial implants, such as bone fixation plates or cranioplasty (aneurysm coils or clips, are acceptable) 5. Recent craniotomy or other reason known for the presence of intra-cranial air 6. Physical inability to wear the investigational device (e.g. skin lesions on scalp, haematomas) 7. Any other condition, which in the judgment of the stroke clinician might prevent the patient from tolerating CBA measurement or brain imaging (e.g. severe agitation or requiring immediate ITU admission)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The diagnostic accuracy of CBA measurement performed using the Cerebrotech Visor System to identify complex stroke in patients arriving at hospital with a paramedic assigned diagnosis of suspected stroke. Complex stroke is defined as ischaemic stroke caused by large vessel occlusion (LVO), or symptomatic severe anterior vessel stenosis, or haemorrhagic stroke =60 ml in volume, or previous territorial stroke. 2. The diagnostic accuracy of CBA measurement performed using the Cerebrotech Visor System to identify only ischaemic stroke caused by LVO in patients arriving at hospital with a paramedic assigned diagnosis of suspected acute stroke. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed