Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Acute Coronary Syndrome	Procedure: Teleconsultation	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndromes
Study Start Date :	August 2012
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	September 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.	Procedure: Teleconsultation; Teleconsultation of an EMS physician to support the paramedics in acute coronary syndromes
No Intervention: Historical Matched Pairs; Historical matched pairs were searched from local protocols. During this phase no teleconsultation system was existent.

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Inhospital time intervals in STEMI [ Time Frame: up to 12 hours ]
   contact to balloon time, arrival to balloon time
2. Rate of secondary transfer for PCI [ Time Frame: up to 7 days ]
   Rate of secondary transfer to a different facility for PCI
3. Troponin-Level [ Time Frame: 24 hours ]
   Severity of infarction measured with level of Troponin
4. 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.
5. prehospital time intervals [ Time Frame: average 1 hour ]
   on-scene time, contact (EMS) to hospital arrival time, transport time

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	RWTH Aachen University
ClinicalTrials.gov Identifier:	NCT01644006 History of Changes
Other Study ID Numbers:	005-1003-0034-1; PtJ-Az.: z0909im002b ( Other Grant/Funding Number: PTJ )
First Posted:	July 18, 2012
Last Update Posted:	September 22, 2015
Last Verified:	September 2015

Keywords provided by RWTH Aachen University:

acute coronary syndrome; telemedicine; teleconsultation; emergency medical service

Additional relevant MeSH terms:

Syndrome; Emergencies; Acute Coronary Syndrome; Disease; Pathologic Processes	Disease Attributes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases