Algorithm Development Through AI for the Triage of Stroke Patients in the Ambulance With EEG
Algorithm Development Through Artificial Intelligence for the Triage of Stroke Patients in the Ambulance With Electroencephalography
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1,192 participants
Jun 19, 2022
INTERVENTIONAL
Conditions
Summary
Endovascular thrombectomy (EVT) enormously improves the prognosis of patients with large vessel occlusion (LVO) stroke, but its effect is highly time-dependent. Direct presentation of patients with an LVO stroke to an EVT-capable hospital reduces onset-to-treatment time by 40-115 minutes and thereby improves clinical outcome. Electroencephalography (EEG) may be a suitable prehospital stroke triage instrument for identifying LVO stroke, as differences have been found between EEG recordings of patients with an LVO stroke and those of suspected acute ischemic stroke patients with a smaller or no vessel occlusion. The investigators expect EEG can be performed in less than five minutes in the prehospital setting using a dry electrode EEG cap. An automatic LVO-detection algorithm will be the key to reliable, simple and fast interpretation of EEG recordings by ambulance paramedics. The primary objective of this study is to develop one or more novel AI-based algorithms (the AI-STROKE algorithms) with optimal diagnostic accuracy for identification of LVO stroke in patients with a suspected acute ischemic stroke in the prehospital setting, based on ambulant EEG data.
Eligibility
Inclusion Criteria4
- Suspected AIS, as assessed by the attending ambulance paramedic, or a known LVO stroke;
- Onset of symptoms or last seen well < 24 hours before EEG acquisition;
- Age of 18 years or older;
- Written informed consent by patient or legal representative (deferred).
Exclusion Criteria2
- Skin defect or active infection of the scalp in the area of the electrode cap placement;
- (Suspected) COVID-19 infection.
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Interventions
A single dry electrode electroencephalography (EEG) will be performed in each patient that is included in this study. For this purpose the Waveguard touch dry electrode EEG cap and compatible eego mini amplifier (ANT Neuro B.V., Hengelo, Netherlands) are used to record and amplify the EEG signal, respectively. Both products are CE marked as medical devices in the European Union and will be used within the intended use as described in the user manuals.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05437237