Telemedically Supported Analgesia in the Emergency Medical Service

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the safety and efficacy of telemedically supported and delegated pain therapy in the Emergency Medical Service (EMS).

Detailed Description
-----------------
Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, 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. 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 and can delegate the application of morphine and other analgesics. 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. All regular ambulances of the five districts are not allowed to administer analgesics without an physician on-scene. They have to call an Advanced Life Support response unit, staffed with an EMS physician, who carries out all kinds of ALS interventions. The safety, efficacy and the quality of analgesia should be compared with regular EMS.

Official Title
-----------------
Telemedically Supported Analgesia in the Emergency Medical Service

Conditions
-----------------
Indication for Analgesia, Emergency Medical Service, Teleconsultation

Intervention / Treatment
-----------------
* Other: Teleconsultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Verbal consent obtained or patient is unable to consent due to the severity of the emergency Indication for analgesia Exclusion Criteria: Refused consent No indication for analgesia
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device_ Teleconsultation<br>Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, 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. 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 and can delegate the application of morphine and other analgesics. 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, efficacy and the quality of analgesia should be compared with regular EMS. | Other: Teleconsultation<br>* Teleconsultation between paramedics and an EMS physician<br>|
| No Intervention: Historical Control Period<br>After completion of the study arm, matched pairs from a historical phase (without the ability of teleconsultation) were searched. Local cases were always matched with comparable controls from the same location. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications | Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | Pain level measured with numerical rating scale | average 1 hour | 
| Incidence of nausea and vomiting |  | 2 hours | 
| Time intervals | on-scene time, contact to hospital time | average 1 hour | 
| Medications and dosages | Evaluation and description of the used medications and dosages | average 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemedicine, teleconsultation, analgesia, emergency, prehospital