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临床试验/NCT05388071
NCT05388071已完成不适用

The Tele-senior EMS Physician as a Strategy for the Future of Disaster Medicine - a Study Testing the Feasibility of Telemedicine in Civil Defense: Feasibility of Telemedicine Under Ambulance Station Conditions

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 404 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
404
试验地点
1
主要终点
Change of triage category using the German PRIOR algorithm (Primäres Ranking zur initialen Orientierung im Rettungsdienst)

研究概览

简要总结

Our aim is to evaluate the feasibility of telemedicine in context of medical service in an ambulance station and in a further step in context of civil defense situations.

The conditions in those situations are different to the usual usage of telemedicine in context of emergency medical services (EMS) like the "Telenotarzt" in Aachen. The medical personnel who are performing the medical treatment in ambulance stations or civil defense situations are most volunteers and are ordinarily not as experienced and educated as professional medical personnel in EMS. In case of civil defense situations, the personnel also must deal with shortage in material which we are not going to simulate in our study.

The study will be realized at each one ambulance station at four large-scale events. Every time there will be a telemedicine workspace with an EMS-physician educated in telemedicine who can be contacted by briefed and equipped medical personnel according to the "TeleSAN"-standard. The emergency personnel start the patient's treatment according to their known standards and decide on their own whether they want to contact the tele-EMS-physician or not.

Before starting the tele-consultation, every patient must declare his consent to the tele-consultation, otherwise tele-consultation cannot be realized, and the patient needs to be treated according to common standards.

Due to spatial proximity of the telemedicine workspace and the ambulance station, the tele-EMS-physician can also work as an EMS-physician in the ambulance station if necessary.

As a hypothesis we declare that telemedicine is feasible in context of an ambulance station. To evaluate the feasibility, we use patient's medical protocols, observations and surveys.

详细描述

To evaluate the feasibility of telemedicine in context of an ambulance station with all the given restrictions compared to usage of telemedicine in emergency medical services (EMS), we will set up each one ambulance station at four large-scale events in Germany with a telemedicine infrastructure. The ambulance stations at such events are the primary place to go for visitors to get a primary medical care and is also used as a primary place for the patients of medical service providers on feet.

As part of the telemedicine infrastructure, educated personnel is required. The study protocol defines that any medical personnel with the ability to use telemedicine must be declared as a "Rettungssanitäter/in", a special paramedic qualification in Germany comparable to an EMT-I/85 (Intermediate) in the USA. These emergency personnel are called "TeleSAN".

Before the assignment in the ambulance station starts, every TeleSAN will be educated and briefed in the usage of the telemedical devices. The used equipment has been evaluated in context of the research project "TeleSAN" at the AcuteCare InnovationHub, University Hospital Aachen, Germany and is composed of a smartphone with a TeleSAN-app, a headset, and a camera. In addition to that, every TeleSAN in the ambulance station will be equipped with a Bluetooth-medical-device-set consisting of a mini-ECG, a blood glucose meter, a blood pressure cuff and a bluetooth-stethoscope which can stream all data in real-time to the tele-EMS-physician.

To stream the data and as a communication platform, the "TeleDoc"-App for video-consultation and the "TeleSAN"-App which is based on the "TeleDoc"-App with a focus on disaster medicine, both developed by Docs in Clouds TeleCare GmbH, Aachen, Germany, will be used.

Every patient who enters the ambulance station will be informed that a telemedicine-study is going on. In addition to that, the protocol defines a separate enlightenment for every patient who will be treated by telemedicine through the TeleSAN-operator before the teleconsultation starts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • full legal age
  • capacity to consent

排除标准

  • acute failure of breathing
  • cardiac arrest
  • unconsciousness
  • status epilepticus
  • life-threatening arrhythmia
  • polytrauma
  • non-manageable symptoms of a mental illness, self-endangerment, danger to others
  • imminent birth
  • serious traffic accident or traffic accident with children involved
  • fall from a great height (>3m)
  • gunshot or knife wounds to the head, neck or torso
  • fire with personal damage
  • high-voltage accident
  • water accidents (drowning, swimming accidents, breaking in the ice)
  • accidents with involvement of hazardous substances
  • killing spree, hostage situations or other situations which endanger the lives of the medical personnel
  • imminent threat of suizide
  • non-consent

结局指标

主要结局

Change of triage category using the German PRIOR algorithm (Primäres Ranking zur initialen Orientierung im Rettungsdienst)

时间窗: through study completion, in total estimated 1 year

Changes of the patient's medical condition will be measured using the german PRIOR algorithm which is used to triage patients in three categories: red, yellow and green. A change of triage category from red to yellow/green or from yellow to green means a better outcome, a change from green to yellow/red means a worse outcome.

Improvement of NACA-Score (National Advisory Committee for Aeronautics)

时间窗: through study completion, in total estimated 1 years

Changes of the patient's medical condition will be measured using the NACA-Score. Changes from a lower to a higher score means a worse outcome.

Improvement of vital signs

时间窗: through study completion, in total estimated 1 year

Changes of the patient's medical condition will be measured by analyzing changes in the patient's vital signs. Changes from unphysiological to physiological vital signs mean a better outcome.

次要结局

  • Usability of the telemedicine-devices and infrastructure and their reliable function(through study completion, in total estimated 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Müller

Principal Investigator, Master of Science, Scientific Staff

RWTH Aachen University

研究点 (1)

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