Single-center Clinical Trial Evaluating the Efficacy, Safety, Feasibility, Reliability, and Cost-effectiveness of In-ambulance Telemedicine for Patients With Suspicion of Acute Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Call-to-brain imaging time
研究概览
简要总结
Interventional prospective randomized open blinded end-point (PROBE) single-center clinical trial on the evaluation of the efficacy, safety, feasibility, reliability, and cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.
详细描述
The purpose of PreSSUB II is to evaluate the efficacy, safety, feasibility, reliability and cost-effectiveness of in-ambulance telemedicine during Paramedic Intervention Team transportation of patients with suspicion of acute stroke.
The implementation of expert stroke support in the pre-hospital arena using in-ambulance telemedicine is an innovative approach that opens up new perspectives and allows continuous guidance by a stroke specialist throughout the acute stroke care continuum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Emergency transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel
- •Age >= 18 years
- •Suspicion of acute stroke with symptom onset < 12 h or unknown, based on any of the symptoms mentioned in the Belgian manual for medical regulation of pre-hospital care: Hemiparesis, Facial asymmetry, Speech disturbance, Sudden, severe headache, or Confusion.
排除标准
- •Patients for whom in-ambulance telemedicine consultation would delay any diagnostic or therapeutic intervention.
结局指标
主要结局
Call-to-brain imaging time
时间窗: within 2 hours
Interval between emergency call and imaging of the brain by computed tomography or magnetic resonance imaging in the hospital.
次要结局
- Medical events during in-ambulance telemedicine(within 2 hours)
- Clinical outcome(upto 12 months)
- Recanalisation therapy(upto 8 hours)
研究者
Raf Brouns, MD, PhD
MD PhD
Universitair Ziekenhuis Brussel