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Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT01644006
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

July 12, 2012
July 18, 2012
September 22, 2015
August 2012
July 2013   (Final data collection date for primary outcome measure)
Quality of prehospital care [ Time Frame: average 1 hour ]
Analysis of the quality of the prehospital care on the basis of published guidelines for ACS / STEMI
Same as current
Complete list of historical versions of study NCT01644006 on ClinicalTrials.gov Archive Site
  • Inhospital time intervals in STEMI [ Time Frame: up to 12 hours ]
    contact to balloon time, arrival to balloon time
  • Rate of secondary transfer for PCI [ Time Frame: up to 7 days ]
    Rate of secondary transfer to a different facility for PCI
  • Troponin-Level [ Time Frame: 24 hours ]
    Severity of infarction measured with level of Troponin
  • Conducted procedures and medications (paramedics) [ Time Frame: average 1 hour ]
    Amount of guidelines based procedures and medications carried out by paramedics prior to the contact with a physician.
  • prehospital time intervals [ Time Frame: average 1 hour ]
    on-scene time, contact (EMS) to hospital arrival time, transport time
  • Inhospital time intervals in STEMI [ Time Frame: up to 12 hours ]
    contact to balloon time, arrival to balloon time
  • Rate of secondary transfer for PCI [ Time Frame: up to 7 days ]
    Rate of secondary transfer to a different facility for PCI
  • Troponin-Level [ Time Frame: 24 hours ]
    Severity of infarction measured with level of Troponin
  • Conducted procedures and medications (paramedics) [ Time Frame: average 1 hour ]
    Amount of guidelines based procedures and medications carried out by paramdics prior to the contact with a physician.
  • prehospital time intervals [ Time Frame: average 1 hour ]
    on-scene time, contact (EMS) to hospital arrival time, transport time
Not Provided
Not Provided
 
Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome
Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndromes
The aim of the study is to investigate the quality of prehospital emergency care in acute coronary syndromes, when paramedics are supported telemedically by an EMS physician.

Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of suspected acute coronary syndrome (including STEMI), 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 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 quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Coronary Syndrome
Procedure: Teleconsultation
Teleconsultation of an EMS physician to support the paramedics in acute coronary syndromes
  • Experimental: Device: Teleconsultation

    In cases of suspected acute coronary syndrome (including STEMI), if patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" with 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 quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.

    Intervention: Procedure: Teleconsultation
  • No Intervention: Historical Matched Pairs
    Historical matched pairs were searched from local protocols. During this phase no teleconsultation system was existent.
Brokmann JC, Conrad C, Rossaint R, Bergrath S, Beckers SK, Tamm M, Czaplik M, Hirsch F. Treatment of Acute Coronary Syndrome by Telemedically Supported Paramedics Compared With Physician-Based Treatment: A Prospective, Interventional, Multicenter Trial. J Med Internet Res. 2016 Dec 1;18(12):e314.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
180
September 2015
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Suspected acute coronary syndrome
  • Verbal consent for teleconsultation obtained or patient is not able to consent due to the severity of the emergency

Exclusion Criteria:

  • Patient refuses consent to teleconsultation
  • No suspected acute coronary syndrome
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01644006
005-1003-0034-1
PtJ-Az.: z0909im002b ( Other Grant/Funding Number: PTJ )
No
Not Provided
Not Provided
RWTH Aachen University
RWTH Aachen University
Not Provided
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
RWTH Aachen University
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP