Operation of a Mobile Telemedicine System in the EMS

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the safety and efficacy of the operation of a prehospital teleconsultation system in the Emergency Medical Service.

Detailed Description
-----------------
Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. The paramedics can use this system to contact a so called tele-EMS physician after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can be transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The safety and efficacy of the introduction and operation of this system should be evaluated.

Official Title
-----------------
Introduction and Operation of a Mobile Telemedicine System to Support Paramedics in the Emergency Medical Service

Conditions
-----------------
Prehospital Emergency, Teleconsultation, Safety

Intervention / Treatment
-----------------
* Procedure: Teleconsultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prehospital emergency consent of the patient for teleconsultation was obtained or patient is unable to consent due to the severity of the emergency Exclusion Criteria: patient refuses consent for teleconsultation psychiatric emergency
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: Teleconsultation<br>If patients give informed consent the paramedics can use this system to contact a so called tele-EMS physician with an audio-connection to the EMS team who receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can be transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The safety and efficacy of the introduction and operation of this system should be evaluated. | Procedure: Teleconsultation<br>* Teleconsultation in prehospital emergencies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications | The incidence of complications due to delegated medications should be evaluated. | up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time intervals | on-scene time of EMS, contact (EMS) to hospital arrival time | up to 2 hours | 
| Duration of teleconsultation | Analysis of the time requirement for teleconsultation with respect to the different EMS districts and different emergencies as well as over time. | up to 2 hours | 
| Requirement of on-scene EMS physician | Analysis of the requirement of an on-scene EMS physician in respect to the different emergencies and districts. | up to 2 hours | 
| Technical assessments | Analysis of the technical performance of the system | up to 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergency medical service, telemedicine, teleconsultation, safety