Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome - Full Text View

Purpose

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	Intervention
Acute Coronary Syndrome	Procedure: Teleconsultation


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndromes

Resource links provided by NLM:

MedlinePlus related topics: Emergency Medical Services

U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:

Quality of prehospital care [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]
Analysis of the quality of the prehospital care on the basis of published guidelines for ACS / STEMI

Secondary Outcome Measures:

Inhospital time intervals in STEMI [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]
contact to balloon time, arrival to balloon time
Rate of secondary transfer for PCI [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
Rate of secondary transfer to a different facility for PCI
Troponin-Level [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Severity of infarction measured with level of Troponin
Conducted procedures and medications (paramedics) [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
on-scene time, contact (EMS) to hospital arrival time, transport time


Enrollment:	39
Study Start Date:	August 2012
Study Completion Date:	September 2015
Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644006

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:	NCT01644006 History of Changes
Other Study ID Numbers:	005-1003-0034-1 PtJ-Az.: z0909im002b
Study First Received:	July 12, 2012
Last Updated:	September 21, 2015
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 27, 2016