- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644006
Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome
Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndromes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aachen, Germany, 52074
- University Hospital Aachen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
average 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inhospital time intervals in STEMI
Time Frame: up to 12 hours
|
contact to balloon time, arrival to balloon time
|
up to 12 hours
|
|
Rate of secondary transfer for PCI
Time Frame: up to 7 days
|
Rate of secondary transfer to a different facility for PCI
|
up to 7 days
|
|
Troponin-Level
Time Frame: 24 hours
|
Severity of infarction measured with level of Troponin
|
24 hours
|
|
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.
|
average 1 hour
|
|
prehospital time intervals
Time Frame: average 1 hour
|
on-scene time, contact (EMS) to hospital arrival time, transport time
|
average 1 hour
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 005-1003-0034-1
- PtJ-Az.: z0909im002b (Other Grant/Funding Number: PTJ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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