Telemedical Support for Prehospital Emergency Medical Service

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-09

Study Completion Date

2019-12-18

Brief Summary

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The purpose of this study is to evaluate the safety and quality of a pre-hospital holistic multifunctional teleconsultation system. This system consists of on-line transmissions of vital parameters, audio- and video-signals from the scene to a telemedicine centre, where a trained emergency physician (tele-EMS physician) uses software-based guideline conform algorithms for diagnosis and treatment.

At the prehospital emergency scene half of the patients will receive this telemedicine-based approach and the other half the conventional emergency physician-based care.

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Detailed Description

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The usual Emergency Medical Services (EMS) in Germany consists of a dual system with two paramedics and one EMS physician on scene.

Telemedicine networks between medical personnel and medical experts were shown to be beneficial for the quality of health care in many medical fields. The investigators have developed a holistic multifunctional mobile EMS teleconsultation system, as a complementary structural element to the ground based and air based EMS. This tele emergency system was evaluated and implemented during two third-party funded telemedicine projects (Med-on-@ix and TemRas) in the city of Aachen, Germany.

The EMS teleconsultation system was step-wise introduced in the clinical routine of Aachen. Several cases (hypertensive emergency cases, stroke, dislocated fractures etc.) with the primary indication for an EMS physician are already dispatched solely to the paramedics, who can demand support by a tele-EMS physician at any time.

Our aim is to demonstrate that the tele-EMS system is non-inferior in comparison to the conventional german EMS physician system with respect to safety. Moreover, the investigators want to evaluate which system provides a better quality with respect to recording important aspects of medical history and a more guideline conform treatment.

Conditions

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Emergency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Conventional EMS physician

The dispatching personnel will evaluate the emergency call severity and after exclusion of the life-threatening cases listed in a written procedure instruction, they will dispatch a conventional EMS physician, if this is the result of the randomization software.

Group Type ACTIVE_COMPARATOR

conventional EMS physician

Intervention Type OTHER

A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures.

Tele-EMS physician

The dispatching personnel will evaluate the emergency call severity and after exclusion of the life-threatening cases listed in a written procedure instruction, they will dispatch a tele-EMS physician, if this is the result of the randomization software.

Group Type OTHER

tele-EMS physician

Intervention Type OTHER

The patients will be treated by the paramedics, which are concurrently instructed by the tele-EMS physicians of the tele consultation center according to the software-based guideline conform algorithms for diagnosis and treatment.

Interventions

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conventional EMS physician

A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures.

Intervention Type OTHER

tele-EMS physician

The patients will be treated by the paramedics, which are concurrently instructed by the tele-EMS physicians of the tele consultation center according to the software-based guideline conform algorithms for diagnosis and treatment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All non-life-threatening emergency calls, which do not obligatory require an EMS physician on scene and which do not solely require an ambulance vehicle staffed with paramedics. study.

Exclusion Criteria

* All life-threatening emergency cases, where a physically present EMS physician on scene is obligatory required. These include:

1. Patient condition related indications:

* Apnea
* Acute respiratory failure
* Cardiocirculatory arrest
* ST-elevation myocardial infarction (STEMI)
* Unconsciousness
* Persistent seizure
* Life- threatening rhythm disorder
* Major trauma
* Complex psychiatric disorders
* Age \< 18 years
2. Emergency case related indications

* Major vehicle accident
* (Traffic) accident with children
* Fall from a height (\> 3m)
* Gunshot-, stab-, or blow injuries in the head, neck and torso area
* Fires with reference to personal injury
* Carbon monoxide intoxication
* Explosion-, thermic or chemical accidents with reference to personal injury
* High-voltage electrical accident
* Water connected accidents (drowning-, diving accident, fall through ice)
* Entrapment or accidental spillage
* Hostage-taking, rampage or other crimes with potential danger for human life (preventive deployment, police consultation)
* Immediate threatening suicide
* Immediate forthcoming delivery or preceding delivery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No