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Completed

NCT Number: NCT05737420

Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting

This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical services is feasible.

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Key information

Conditions

Cerebrovascular Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • In-hospital stroke or private transport to hospital
  • Unconsciousness defined as Glascow Coma Score (GCS) ≤ 8 (as they cannot be rated)

Treatment and study plan

Video call

Diagnostic Test

The on-call neurologist can see and communicate with the patient via live stream video-call.

Primary outcomes

  1. Recruitment Rate

    Time frame: Through study completion, approximately 2 months

    Rate of patients included in the trial amongst all patients screened

  2. Exclusion rate

    Time frame: Through study completion, approximately 2 months

    rate of patients excluded from participation amongst all patients screened

  3. Attrition rate

    Time frame: Through study completion, approximately 5 months

    rate of patients and data lost

  4. Adherence to protocol by the Emergency Medical Services

    Time frame: Baseline (Prehospital examination of patient conducted by Emergency Medical Services)

    Evaluation of missing data in the clinical examination prehospital in Pre-hospital patient journal

  5. Adherence to protocol by the neurologist prehospital

    Time frame: Baseline (Prehospital examination of patient conducted on video by neurologists)

    Evaluation of missing data in the clinical examination conducted with video

  6. Adherence to protocol by the neurologist intrahospital

    Time frame: At admission

    Evaluation of missing data in the National Institute of Health Stroke Scale conducted intrahospital by neurologist

  7. Stakeholder Feedback Survey

    Time frame: immediately after the intervention

    Mixed open-ended and closed (Likert type response) questions to assess trial and intervention acceptability

  8. Patient Feedback Survey

    Time frame: 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

Secondary outcomes

  1. Acute ischemic stroke with Large Vessel Occlusion on neuroimaging

    Time frame: 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.

  2. Other large vessel Acute ischemic stroke

    Time frame: 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

  3. Other Acute ischemic stroke

    Time frame: at admission

    Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with Acute ischemic stroke

  4. Haemorrhagic stroke

    Time frame: at admission

    Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with intra cranial haemorrhage (ICH)

  5. Duration of examination on video-call

    Time frame: up to 60 minutes (prior to admission, prehospital phase)

    Duration of examination on video-call measured in minutes

  6. Mimic mistaken for stroke

    Time frame: 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

  7. Prehospital time on scene

    Time frame: 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

  8. 90 days modified Rankin Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting: A Cluster Randomised Pilot Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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