Clinical trial NCT05388071: Feasibility of Telemedicine Under Ambulance Station Conditions
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Telemedicine
Disaster Medicine
Emergency Medicine
Keywords: TeleSAN
Telemedicine
Remote Consultation
Remote Treatment
Emergency Medical Services
Disaster Medicine
Emergency Medicine
Teleconsultation
Tele-emergency physician
Quality of Health Care
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We assume a cohort out of the total of festival visitors which is composed of 16-40 years old people with occasional older visitors. The patient-collective can be composed of intoxications by alcohol or drugs and minor violations of the extremities. Effects of heat and light can occur as well.

Only those who consent to our study can be part of it, therefore every patient has to give his or her consent to the evaluation of the already bespoken outcome measures and data acquisition.

Brief summary: 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.

Detailed description: 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.

Whether telemedicine will be used for patient's treatment or not is at the discretion of the TeleSAN, who will always start the treatment on his / her own and evaluates if the patient meets any exclusion criteria which would lead to not-usage of telemedicine.

In case of a none-given consent or in case of medical or technical necessity of termination of the teleconsultation, the tele-EMS-physician can work as a regular EMS-physician in the ambulance station thanks to spatial proximity. Therefore, we can guarantee a treatment according to the current medical standards all the time. In addition to the already listed medical devices, we will also have a defibrillator/ECG-monitor, a ventilator and a suction pump available for emergency situations.

The aim is to evaluate if telemedicine is feasible in context of an ambulance station regarding medical protocols, observations, and surveys.

In a further step an assessment of a possible usage of telemedicine in context of civil defense situations will be done.

Eligibility criteria: Inclusion Criteria:

* full legal age
* capacity to consent

Exclusion Criteria:

* apnea
* acute failure of breathing
* cardiac arrest
* STEMI
* 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

Primary outcomes:
measure: Change of triage category using the German PRIOR algorithm (Primäres Ranking zur initialen Orientierung im Rettungsdienst)
timeFrame: through study completion, in total estimated 1 year
measure: Improvement of vital signs
timeFrame: through study completion, in total estimated 1 year
measure: Improvement of NACA-Score (National Advisory Committee for Aeronautics)
timeFrame: through study completion, in total estimated 1 years
Secondary outcomes:
measure: Usability of the telemedicine-devices and infrastructure and their reliable function
timeFrame: through study completion, in total estimated 1 year
Other outcomes:
measure: Time for treatment
timeFrame: through study completion, in total estimated 1 year
measure: Experience and education
timeFrame: through study completion, in total estimated 1 year
measure: Acceptance of telemedicine
timeFrame: through study completion, in total estimated 1 year
measure: Reasons for the usage of telemedicine
timeFrame: through study completion, in total estimated 1 year
measure: Sense of security of the patients treated by teleconsultation
timeFrame: through study completion, in total estimated 1 year
measure: Measures in the context of mass gathering medicine that can be delegated telemedically
timeFrame: retrospectively after all protocols have been evaluated, estimated until September 2023
measure: Number of missions in the Accident Assistance Center that can be handled using telemedicine
timeFrame: retrospectively after all protocols have been evaluated, estimated until September 2023
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
state: North Rhine-Westphalia
Study officials:
affiliation: University Hospital RWTH Aachen, Germany, Anaesthesiology Clinic
name: Rolf Rossaint, Prof. Dr.
role: STUDY_CHAIR
References: