An observational study in Telemedicine, Disaster Medicine and Emergency Medicine, sponsored by RWTH Aachen University. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by RWTH Aachen University · Observational
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.
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 404 is above the median of 353 across 714 observational studies indexed under Emergencies.
Browse Emergencies studies →RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.
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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.
Exclusion Criteria:
Telemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible.
Other: Usage of telemedicine and tele-consultation for treatment
Treatment will be performed as usual without the usage of telemedicine.
Telemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible.
Change of triage category using the German PRIOR algorithm (Primäres Ranking zur initialen Orientierung im Rettungsdienst)
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.
Time frame: through study completion, in total estimated 1 year
Improvement of vital signs
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.
Time frame: through study completion, in total estimated 1 year
Improvement of NACA-Score (National Advisory Committee for Aeronautics)
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.
Time frame: through study completion, in total estimated 1 years
Usability of the telemedicine-devices and infrastructure and their reliable function
By analyzation of observation protocols, patient-surveys and personnel-surveys, the usability and the reliability can be evaluated
Time frame: through study completion, in total estimated 1 year
Time for treatment
time needed for treatment using telemedicine, also regarding binding time for the physician and end of telemedicinal delegated treatment
Time frame: through study completion, in total estimated 1 year
Experience and education
Using surveys for the medical personnel, experience and education can be evaluated on the one hand for medical experience and education and on the other hand for experience an education concerning telemedicine
Time frame: through study completion, in total estimated 1 year
Acceptance of telemedicine
By analyzation of surveys an evaluation of the personnel's acceptance of telemedicine will be performed
Time frame: through study completion, in total estimated 1 year
Reasons for the usage of telemedicine
By analyzation of the medical protocols and in addition surveys and observation protocols, an evaluation of the reasons for the usage of telemedicine will be performed
Time frame: through study completion, in total estimated 1 year
Sense of security of the patients treated by teleconsultation
By analyzation of surveys and observation protocols, an evaluation of the sense of security of the patients treated by teleconsultation will be performed
Time frame: through study completion, in total estimated 1 year
Measures in the context of mass gathering medicine that can be delegated telemedically
By analyzing all mission logs, the measures carried out by telemedicine and those carried out by on-site personnel without telemedicine are recorded. Subsequently, a three-stage Delphi process is carried out in which experienced tele-EMS-physicians use case descriptions to decide whether the measure can be delegated via telemedicine in the context of this case description.
Time frame: retrospectively after all protocols have been evaluated, estimated until September 2023
Number of missions in the Accident Assistance Center that can be handled using telemedicine
The results of the Delphi process (described in Outcome 10) can be used to evaluate what proportion of all cases that occurred could have been handled using telemedicine.
Time frame: retrospectively after all protocols have been evaluated, estimated until September 2023
Plan to share: No
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RWTH Aachen University