Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting
- Conditions
- Central Nervous System DiseasesCerebrovascular DisordersVascular DiseasesBrain DiseasesStrokeNervous System Diseases
- Interventions
- Diagnostic Test: Video call
- Registration Number
- NCT05737420
- Lead Sponsor
- University of Southern Denmark
- Brief Summary
This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical services is feasible.
- Detailed Description
Multiple stroke severity scales have been coined in order to examine patients suspected of stroke in a prehospital setting in order to identify and transfer patients eligible for thrombectomy directly to a comprehensive stroke centre (CSC). However, performance and feasibility vary greatly in different validation studies suggesting that those outcomes are greatly dependent on other factors i.e. acceptance amongst stakeholders, implementation process, patient segment etc. Some recent studies have shown promising results using telemedicine i.e. video solutions between emergency medical services (EMS) personnel and on-call neurologist in examining patients suspected of stroke in the prehospital phase. The investigators will perform this trial to examine whether a cluster randomised trial with video call assisted assessment of patients suspected of stroke in a prehospital setting is an appropriate trial design and feasible with regard to recruitment and retention, acceptability among stakeholders (EMS and neurologists) as well as patients and lastly with regard to stakeholders' adherence to protocol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Suspected stroke within 24 hours from onset (confirmed with Pre-hospital stroke score 1 ≥1)
- Catchment area of Hospital Sønderjylland
- Deferred informed consent obtained from patient or patient surrogate
- In-hospital stroke or private transport to hospital
- Unconsciousness defined as Glascow Coma Score (GCS) ≤ 8 (as they cannot be rated)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional video call Video call All patients suspected of stroke in a prehospital setting are examined according to a prehospital stroke score. The emergency services personnel then contact the on-call neurologist and a live video stream is initiated. The on-call neurologist then examines the patient via the video-call.
- Primary Outcome Measures
Name Time Method Stakeholder Feedback Survey immediately after the intervention Mixed open-ended and closed (Likert type response) questions to assess trial and intervention acceptability
Exclusion rate Through study completion, approximately 2 months rate of patients excluded from participation amongst all patients screened
Patient Feedback Survey Between the day after admission and 5 days after admission Semistructured interview with open-ended and closed (Likert type response) questions to assess intervention acceptability
Adherence to protocol by the Emergency Medical Services Baseline (Prehospital examination of patient conducted by Emergency Medical Services) Evaluation of missing data in the clinical examination prehospital in Pre-hospital patient journal
Adherence to protocol by the neurologist intrahospital At admission Evaluation of missing data in the National Institute of Health Stroke Scale conducted intrahospital by neurologist
Recruitment Rate Through study completion, approximately 2 months Rate of patients included in the trial amongst all patients screened
Attrition rate Through study completion, approximately 5 months rate of patients and data lost
Adherence to protocol by the neurologist prehospital Baseline (Prehospital examination of patient conducted on video by neurologists) Evaluation of missing data in the clinical examination conducted with video
- Secondary Outcome Measures
Name Time Method Duration of examination on video-call up to 60 minutes (prior to admission, prehospital phase) Duration of examination on video-call measured in minutes
Mimic mistaken for stroke Through study completion, approximately 2 months Mimic mistaken for stroke evaluated as discrepancy between stroke as tentative diagnoses at primary contact from EMS and final diagnosis at discharge
Acute ischemic stroke with Large Vessel Occlusion on neuroimaging At admission Acute ischemic stroke with Large Vessel Occlusion (LVO) on neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography). LVO is defined as an occlusion or sub-occlusion of the intracranial internal carotid artery, middle cerebral artery M1 or M2, basilar artery. Sign of a dense cerebral artery on CT is also considered LVO positive.
Other large vessel Acute ischemic stroke at admission Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with AIS with occlusion or sub-occlusion of either anterior cerebral artery A1 or A2, posterior cortical artery P1 or intracranial vertebral artery
Other Acute ischemic stroke at admission Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with Acute ischemic stroke
Haemorrhagic stroke at admission Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with intra cranial haemorrhage (ICH)
Prehospital time on scene up to 60 minutes (at prehospital contact) Time on scene from arrival of Emergency Medical Services to departure of Emergency Medical Services measured in minutes
90 days modified Rankin Scale 90 days post admission date Modified Rankin Scale score in stroke patients as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment
Trial Locations
- Locations (1)
Sygehus Soenderjylland
🇩🇰Aabenraa, Denmark