Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01644006
First received: July 12, 2012
Last updated: August 22, 2013
Last verified: August 2013
  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: 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:


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


Estimated Enrollment: 180
Study Start Date: August 2012
Estimated Study Completion Date: March 2014
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

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
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

No publications provided

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: August 22, 2013
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:
Emergencies
Acute Coronary Syndrome
Disease Attributes
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014