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Operation of a Mobile Telemedicine System in the EMS

This study is currently recruiting participants.
Verified August 2012 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01647854
First received: July 16, 2012
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Prehospital Emergency
Teleconsultation
Safety
 Procedure: Teleconsultation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Rate of complications [ Time Frame: up to 2 hours ] [ Designated as safety issue: Yes ]
    The incidence of complications due to delegated medications should be evaluated.


Secondary Outcome Measures:
  • Time intervals [ Time Frame: up to 2 hours ] [ Designated as safety issue: No ]
    on-scene time of EMS, contact (EMS) to hospital arrival time

  • Duration of teleconsultation [ Time Frame: up to 2 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 2 hours ] [ Designated as safety issue: No ]
    Analysis of the requirement of an on-scene EMS physician in respect to the different emergencies and districts.

  • Technical assessments [ Time Frame: up to 2 hours ] [ Designated as safety issue: No ]
    Analysis of the technical performance of the system


Estimated Enrollment: 1250
Study Start Date: August 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647854

Contacts
Contact: Rolf Rossaint, Prof. Dr. +49-241-8088179 anaesthesiologie@ukaachen.de

Locations
Germany
University Hospital Aachen Recruiting
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

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01647854     History of Changes
Other Study ID Numbers: 005-1003-0034-5, PtJ-Az.: z0909im002b
Study First Received: July 16, 2012
Last Updated: August 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013