Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome

NCT ID: NCT01644006

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Teleconsultation

Intervention Type PROCEDURE

Teleconsultation of an EMS physician to support the paramedics in acute coronary syndromes

Historical Matched Pairs

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Teleconsultation

Teleconsultation of an EMS physician to support the paramedics in acute coronary syndromes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rolf Rossaint, Prof. Dr.

Role: STUDY_CHAIR

University Hospital Aachen, Germany, Department of Anesthesiology

Jörg C Brokmann, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Aachen, Germany, Emergency Department

Locations

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University Hospital Aachen

Aachen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 27908843 (View on PubMed)

Other Identifiers

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PtJ-Az.: z0909im002b

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

005-1003-0034-1

Identifier Type: -

Identifier Source: org_study_id

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