Operation of a Mobile Telemedicine System in the EMS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01647854|
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : September 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prehospital Emergency Teleconsultation Safety||Procedure: Teleconsultation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||425 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Introduction and Operation of a Mobile Telemedicine System to Support Paramedics in the Emergency Medical Service|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: Device: 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.
Teleconsultation in prehospital emergencies
- Rate of complications [ Time Frame: up to 2 hours ]The incidence of complications due to delegated medications should be evaluated.
- Time intervals [ Time Frame: up to 2 hours ]on-scene time of EMS, contact (EMS) to hospital arrival time
- Duration of teleconsultation [ Time Frame: 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 [ Time Frame: up to 2 hours ]Analysis of the requirement of an on-scene EMS physician in respect to the different emergencies and districts.
- Technical assessments [ Time Frame: up to 2 hours ]Analysis of the technical performance of the system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647854
|University Hospital Aachen|
|Aachen, Germany, 52074|
|Study Chair:||Rolf Rossaint, Prof. Dr.||University Hospital Aachen, Germany, Department of Anesthesiology|
|Principal Investigator:||Jörg C Brokmann, Dr.||University Hospital Aachen, Germany, Emergency Department|