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
- 1
- 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.
研究组 & 干预措施
Control
Standard pre-hospital emergency care by the Paramedic Intervention Team, in accordance with their standing operating procedures.
Telemedicine
In-ambulance teleconsultation by a stroke expert aiming to support the Paramedic Intervention Team by focusing on patient identification, obtaining homeostasis (optimal control of blood pressure, blood oxygenation, temperature, heart rate and rhythm, glycemia), assessment of the patient's neurological status, stroke diagnosis, hospital notification, and patient selection for specific stroke treatment.
干预措施: Telemedicine (Other)
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