Video Call Assisted Assessment of Acute Stroke in Addition to Stroke Scales in a Prehospital Setting: A Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 512
- 试验地点
- 2
- 主要终点
- Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis at discharge
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected stroke within 24 hours from onset (confirmed with Prehospital Stroke 1 decision tool)
- •Age >18 years
排除标准
- •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)
研究组 & 干预措施
Video call assisted assessment of acute stroke
If the patient is eligible for study inclusion, the last symptoms from the study protocol are evaluated and registered in the Prehospital Patient Journal (PPJ) on the amPHITM Prehospital Health Care Record (Amphi Systems, Hasserisvej 125, 9000 Aalborg, Denmark), on a tablet mounted in each EMT vehicle. Afterwards the EMS personnel will contact the on-call neurologist and if the vehicle is in the intervention arm a live video stream is initiated. The on-call neurologist then examines the patient via the video-call and triage the patient.
干预措施: Video call assisted assessment of acute stroke (Diagnostic Test)
Standard Care
If the patient is eligible for study inclusion, eight symptoms from the study protocol are evaluated and registered in the Prehospital Patient Journal (PPJ) on the amPHITM Prehospital Health Care Record (Amphi Systems, Hasserisvej 125, 9000 Aalborg, Denmark), on a tablet mounted in each EMT vehicle. If the vehicle is in the control arm the patient is triaged by the on-call neurologist based on a standard telephone call
结局指标
主要结局
Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis at discharge
时间窗: At discharge, assessed within one week from symptom onset
AIS or TIA as diagnosis. (binary outcome)
次要结局
- Number of patients with Haemorrhagic stroke(at admission)
- Number of patients with verified acute ischemic stroke (AIS) on neuroimaging(Within 48 hours of admission)
- Number of patients with Other large vessel AIS(at admission)
- Number of patients with acute ischemic stroke (AIS) with LVO on neuroimaging(Within 48 hours of admission)