Telemedical Support for Prehospital Emergency Medical Service - a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,534
- 试验地点
- 2
- 主要终点
- Intervention-related adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and quality of a pre-hospital holistic multifunctional teleconsultation system. This system consists of on-line transmissions of vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a trained emergency physician (tele-EMS physician) uses software-based guideline conform algorithms for diagnosis and treatment.
At the prehospital emergency scene half of the patients will receive this telemedicine-based approach and the other half the conventional emergency physician-based care.
详细描述
The usual Emergency Medical Services (EMS) in Germany consists of a dual system with two paramedics and one EMS physician on scene.
Telemedicine networks between medical personnel and medical experts were shown to be beneficial for the quality of health care in many medical fields. The investigators have developed a holistic multifunctional mobile EMS teleconsultation system, as a complementary structural element to the ground based and air based EMS. This tele emergency system was evaluated and implemented during two third-party funded telemedicine projects (Med-on-@ix and TemRas) in the city of Aachen, Germany.
The EMS teleconsultation system was step-wise introduced in the clinical routine of Aachen. Several cases (hypertensive emergency cases, stroke, dislocated fractures etc.) with the primary indication for an EMS physician are already dispatched solely to the paramedics, who can demand support by a tele-EMS physician at any time.
Our aim is to demonstrate that the tele-EMS system is non-inferior in comparison to the conventional german EMS physician system with respect to safety. Moreover, the investigators want to evaluate which system provides a better quality with respect to recording important aspects of medical history and a more guideline conform treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •All non-life-threatening emergency calls, which do not obligatory require an EMS physician on scene and which do not solely require an ambulance vehicle staffed with paramedics. study.
排除标准
- •All life-threatening emergency cases, where a physically present EMS physician on scene is obligatory required. These include:
- •Patient condition related indications:
- •Acute respiratory failure
- •Cardiocirculatory arrest
- •ST-elevation myocardial infarction (STEMI)
- •Unconsciousness
- •Persistent seizure
- •Life- threatening rhythm disorder
- •Major trauma
- •Complex psychiatric disorders
- •Age < 18 years
- •Emergency case related indications
- •Major vehicle accident
- •(Traffic) accident with children
- •Fall from a height (> 3m)
- •Gunshot-, stab-, or blow injuries in the head, neck and torso area
- •Fires with reference to personal injury
- •Carbon monoxide intoxication
- •Explosion-, thermic or chemical accidents with reference to personal injury
- •High-voltage electrical accident
- •Water connected accidents (drowning-, diving accident, fall through ice)
- •Entrapment or accidental spillage
- •Hostage-taking, rampage or other crimes with potential danger for human life (preventive deployment, police consultation)
- •Immediate threatening suicide
- •Immediate forthcoming delivery or preceding delivery
结局指标
主要结局
Intervention-related adverse events
时间窗: 1 day
* Allergic reaction to drug application due to incorrect survey of patients' medical history * Intervention-related and immediate treatment requiring blood pressure drop * Intervention-related apnea or respiratory insufficiency * Intervention-related circulatory arrest
次要结局
- Treatment associated quality indicator(1 day)
- Treatment quality(1 day)
- Quality of the EMS-case data documentation(1 day)
- Conversion of the initial dispatched tele-EMS treatment(1 day)
- Death(30 days)
- Duration of the physician engagement-time(1 day)
- Intensive Care Unit (ICU) length of stay(30 days)
- Number of conventional EMS physician operations, which could be handled by a tele-EMS physician(1 day)
- Fulfillment of predefined quality indicators for "Tracer" diagnoses(1 day)
- Hospital length of stay(30 days)
- Correct pre-hospital diagnosis(30 days)
- Adverse events independently of the kind of EMS care(30 days)
- Premature termination of the telemedical or conventional EMS operation(1 day)