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Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Teleconsultation
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, telemedicine, teleconsultation, emergency medical service

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Device: Teleconsultation

Historical Matched Pairs

Arm Description

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.

Historical matched pairs were searched from local protocols. During this phase no teleconsultation system was existent.

Outcomes

Primary Outcome Measures

Quality of prehospital care
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
contact to balloon time, arrival to balloon time
Rate of secondary transfer for PCI
Rate of secondary transfer to a different facility for PCI
Troponin-Level
Severity of infarction measured with level of Troponin
Conducted procedures and medications (paramedics)
Amount of guidelines based procedures and medications carried out by paramedics prior to the contact with a physician.
prehospital time intervals
on-scene time, contact (EMS) to hospital arrival time, transport time

Full Information

First Posted
July 12, 2012
Last Updated
September 21, 2015
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01644006
Brief Title
Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome
Official Title
Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
acute coronary syndrome, telemedicine, teleconsultation, emergency medical service

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device: Teleconsultation
Arm Type
Experimental
Arm Description
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.
Arm Title
Historical Matched Pairs
Arm Type
No Intervention
Arm Description
Historical matched pairs were searched from local protocols. During this phase no teleconsultation system was existent.
Intervention Type
Procedure
Intervention Name(s)
Teleconsultation
Intervention Description
Teleconsultation of an EMS physician to support the paramedics in acute coronary syndromes
Primary Outcome Measure Information:
Title
Quality of prehospital care
Description
Analysis of the quality of the prehospital care on the basis of published guidelines for ACS / STEMI
Time Frame
average 1 hour
Secondary Outcome Measure Information:
Title
Inhospital time intervals in STEMI
Description
contact to balloon time, arrival to balloon time
Time Frame
up to 12 hours
Title
Rate of secondary transfer for PCI
Description
Rate of secondary transfer to a different facility for PCI
Time Frame
up to 7 days
Title
Troponin-Level
Description
Severity of infarction measured with level of Troponin
Time Frame
24 hours
Title
Conducted procedures and medications (paramedics)
Description
Amount of guidelines based procedures and medications carried out by paramedics prior to the contact with a physician.
Time Frame
average 1 hour
Title
prehospital time intervals
Description
on-scene time, contact (EMS) to hospital arrival time, transport time
Time Frame
average 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Rossaint, Prof. Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Department of Anesthesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jörg C Brokmann, Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Emergency Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27908843
Citation
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. doi: 10.2196/jmir.6358.
Results Reference
derived

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Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome

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