Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

Official title:

Telemedical Support in Prehospital Emergency Care of Acute Coronary Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644006
• Other study ID #: 005-1003-0034-1
• Secondary ID: PtJ-Az.: z0909im
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: September 21, 2015
• Start date: August 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Emergencies
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of prehospital care	Analysis of the quality of the prehospital care on the basis of published guidelines for ACS / STEMI	average 1 hour	No
Secondary	Inhospital time intervals in STEMI	contact to balloon time, arrival to balloon time	up to 12 hours	No
Secondary	Rate of secondary transfer for PCI	Rate of secondary transfer to a different facility for PCI	up to 7 days	No
Secondary	Troponin-Level	Severity of infarction measured with level of Troponin	24 hours	No
Secondary	Conducted procedures and medications (paramedics)	Amount of guidelines based procedures and medications carried out by paramedics prior to the contact with a physician.	average 1 hour	No
Secondary	prehospital time intervals	on-scene time, contact (EMS) to hospital arrival time, transport time	average 1 hour	No