Clinical trial NCT06570681: Video Call Assisted Assessment of Acute Stroke
Official title: Video Call Assisted Assessment of Acute Stroke in Addition to Stroke Scales in a Prehospital Setting: A Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Cerebrovascular Disorders
Brain Diseases
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical technicians can increase feasibility and performance of symptom-based prehospital stroke scales.

Detailed description: Treatment of stroke with either thrombolysis or thrombectomy is highly time-dependent (administration within 4.5 hours and 24 hours from symptom onset, respectively), and morbidity and mortality increase with time from symptom onset to treatment. Hence, prehospital evaluation and transport must be as accurate and rapid as possible in order to minimise time to treatment.

Different triage and transport paradigms for patients with suspected stroke are being investigated and multiple stroke scales have been coined in order to examine patients suspected of stroke in a prehospital setting. 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 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 video call assisted assessment of patients suspected of stroke in a prehospital setting can increase feasibility and performance of symptom-based prehospital stroke scales.

Eligibility criteria: Inclusion Criteria:

* Suspected stroke within 24 hours from onset (confirmed with Prehospital Stroke 1 decision tool)
* Age \>18 years

Exclusion Criteria:

* Suspected stroke more than 24 hours ago
* In-hospital stroke or private transport to hospital
* Unconsciousness defined as Glasgow Coma Score (GCS) ≤ 8 (as they cannot be rated)

Primary outcomes:
measure: Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis at discharge
timeFrame: At discharge, assessed within one week from symptom onset
Secondary outcomes:
measure: Number of patients with acute ischemic stroke (AIS) with LVO on neuroimaging
timeFrame: Within 48 hours of admission
measure: Number of patients with Other large vessel AIS
timeFrame: at admission
measure: Number of patients with verified acute ischemic stroke (AIS) on neuroimaging
timeFrame: Within 48 hours of admission
measure: Number of patients with Haemorrhagic stroke
timeFrame: at admission
Other outcomes:
measure: Duration of examination on video-call
timeFrame: up to 120 minutes prior to admission (prehospital phase)
measure: Number of patients which have mimic mistaken for stroke
timeFrame: Through study completion, approximately 2 months
measure: Prehospital time on scene
timeFrame: up to 120 minutes prior to admission (prehospital phase)
measure: Type of department patient is admitted to after consultation with the neurologist
timeFrame: At admission
measure: Door-in-door-out (DIDO) time
timeFrame: at admission
measure: Door-to-needle (DNT) time
timeFrame: at admission
measure: Door-to-Groin-Puncture (DTGP) time
timeFrame: within 24 hours of admission
measure: Onset-to-Groin-Puncture (OTP) time
timeFrame: within 24 hours of admission
measure: 90 days modified Ranking Scale (mRS)
timeFrame: 90 days post admission date
Locations:
city: Aabenraa
country: Denmark
facility: Department of Neurology
state: South Denmark
Study officials:
References: