Operation of a Mobile Telemedicine System in the EMS

Not Applicable

Completed

• Conditions: Prehospital Emergency; Teleconsultation; Safety
• Interventions: Procedure: Teleconsultation

• Registration Number: NCT01647854
• Lead Sponsor: RWTH Aachen University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Study Start: 2012-08
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device: Teleconsultation	Teleconsultation	If patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" with an audio-connection to the EMS team who 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.

Primary Outcome Measures

Name	Time	Method
Rate of complications	up to 2 hours	The incidence of complications due to delegated medications should be evaluated.

Secondary Outcome Measures

Name	Time	Method
Technical assessments	up to 2 hours	Analysis of the technical performance of the system
Time intervals	up to 2 hours	on-scene time of EMS, contact (EMS) to hospital arrival time
Duration of teleconsultation	up to 2 hours	Analysis of the time requirement for teleconsultation with respect to the different EMS districts and different emergencies as well as over time.
Requirement of on-scene EMS physician	up to 2 hours	Analysis of the requirement of an on-scene EMS physician in respect to the different emergencies and districts.

Trial Locations

Locations (1)

University Hospital Aachen; 🇩🇪 Aachen, Germany