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Operation of a Mobile Telemedicine System in the EMS

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ClinicalTrials.gov Identifier: NCT01647854
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Prehospital Emergency Teleconsultation Safety Procedure: Teleconsultation

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 425 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Introduction and Operation of a Mobile Telemedicine System to Support Paramedics in the Emergency Medical Service
Study Start Date : August 2012
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Rate of complications [ Time Frame: up to 2 hours ]
    The incidence of complications due to delegated medications should be evaluated.


Secondary Outcome Measures :
  1. Time intervals [ Time Frame: up to 2 hours ]
    on-scene time of EMS, contact (EMS) to hospital arrival time

  2. 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.

  3. 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.

  4. Technical assessments [ Time Frame: up to 2 hours ]
    Analysis of the technical performance of the system


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647854


Locations
Germany
University Hospital Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Chair: Rolf Rossaint, Prof. Dr. University Hospital Aachen, Germany, Department of Anesthesiology
Principal Investigator: Jörg C Brokmann, Dr. University Hospital Aachen, Germany, Emergency Department
More Information

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01647854     History of Changes
Other Study ID Numbers: 005-1003-0034-5
PtJ-Az.: z0909im002b ( Other Grant/Funding Number: PTJ )
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by RWTH Aachen University:
emergency medical service
telemedicine
teleconsultation
safety

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes