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Operation of a Mobile Telemedicine System in the EMS

Primary Purpose

Prehospital Emergency, Teleconsultation, Safety

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Teleconsultation
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prehospital Emergency focused on measuring emergency medical service, telemedicine, teleconsultation, safety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Aachen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device: Teleconsultation

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of complications
The incidence of complications due to delegated medications should be evaluated.

Secondary Outcome Measures

Time intervals
on-scene time of EMS, contact (EMS) to hospital arrival time
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.
Requirement of on-scene EMS physician
Analysis of the requirement of an on-scene EMS physician in respect to the different emergencies and districts.
Technical assessments
Analysis of the technical performance of the system

Full Information

First Posted
July 16, 2012
Last Updated
September 22, 2015
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01647854
Brief Title
Operation of a Mobile Telemedicine System in the EMS
Official Title
Introduction and Operation of a Mobile Telemedicine System to Support Paramedics in the Emergency Medical Service
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehospital Emergency, Teleconsultation, Safety
Keywords
emergency medical service, telemedicine, teleconsultation, safety

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
425 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device: Teleconsultation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Teleconsultation
Intervention Description
Teleconsultation in prehospital emergencies
Primary Outcome Measure Information:
Title
Rate of complications
Description
The incidence of complications due to delegated medications should be evaluated.
Time Frame
up to 2 hours
Secondary Outcome Measure Information:
Title
Time intervals
Description
on-scene time of EMS, contact (EMS) to hospital arrival time
Time Frame
up to 2 hours
Title
Duration of teleconsultation
Description
Analysis of the time requirement for teleconsultation with respect to the different EMS districts and different emergencies as well as over time.
Time Frame
up to 2 hours
Title
Requirement of on-scene EMS physician
Description
Analysis of the requirement of an on-scene EMS physician in respect to the different emergencies and districts.
Time Frame
up to 2 hours
Title
Technical assessments
Description
Analysis of the technical performance of the system
Time Frame
up to 2 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Rossaint, Prof. Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Department of Anesthesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jörg C Brokmann, Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Emergency Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Operation of a Mobile Telemedicine System in the EMS

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