Operation of a Mobile Telemedicine System in the EMS

Safety Clinical Trial

Official title:

Introduction and Operation of a Mobile Telemedicine System to Support Paramedics in the Emergency Medical Service

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647854
• Other study ID #: 005-1003-0034-5
• Secondary ID: PtJ-Az.: z0909im
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: September 22, 2015
• Start date: August 2012
• Est. completion date: May 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 safety and efficacy of the operation of a prehospital teleconsultation system in the Emergency Medical Service.

Description:

Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. 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 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 safety and efficacy of the introduction and operation of this system should be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• prehospital emergency

• consent of the patient for teleconsultation was obtained or patient is unable to consent due to the severity of the emergency

Exclusion Criteria:

• patient refuses consent for teleconsultation

• psychiatric emergency

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Emergencies
• Prehospital Emergency
• Safety
• Teleconsultation

Intervention

Procedure:
• Teleconsultation
Teleconsultation in prehospital emergencies

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	Rate of complications	The incidence of complications due to delegated medications should be evaluated.	up to 2 hours	Yes
Secondary	Time intervals	on-scene time of EMS, contact (EMS) to hospital arrival time	up to 2 hours	No
Secondary	Duration of teleconsultation	Analysis of the time requirement for teleconsultation with respect to the different EMS districts and different emergencies as well as over time.	up to 2 hours	No
Secondary	Requirement of on-scene EMS physician	Analysis of the requirement of an on-scene EMS physician in respect to the different emergencies and districts.	up to 2 hours	No
Secondary	Technical assessments	Analysis of the technical performance of the system	up to 2 hours	No