Operation of a Mobile Telemedicine System in the EMS

September 22, 2015 updated by: RWTH Aachen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • University Hospital Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Device: Teleconsultation
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
Teleconsultation in prehospital emergencies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications
Time Frame: up to 2 hours
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
Time Frame: up to 2 hours
on-scene time of EMS, contact (EMS) to hospital arrival time
up to 2 hours
Duration of teleconsultation
Time Frame: up to 2 hours
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
Time Frame: up to 2 hours
Analysis of the requirement of an on-scene EMS physician in respect to the different emergencies and districts.
up to 2 hours
Technical assessments
Time Frame: up to 2 hours
Analysis of the technical performance of the system
up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (ESTIMATE)

July 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005-1003-0034-5
  • PtJ-Az.: z0909im002b (Other Grant/Funding Number: PTJ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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