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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01644045
Other study ID # 005-1003-0034-4
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 respiratory emergencies, 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 acute obstructive, respiratory emergencies the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient was 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. The transmission of still pictures (taken with a smartphone), 12-lead-ECGs and video streaming from the inside of the ambulance can also be carried out, if indicated. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, 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 17
Est. completion date September 2015
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Obstructive, respiratory emergency

- Verbal consent for teleconsultation obtained or patient is not able to consent due the severity of the emergency

Exclusion Criteria:

- No respiratory emergency

- Refused consent for teleconsultation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Teleconsultation
Teleconsultation for the EMS in acute respiratory 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 Oxygen Saturation Measurement of pulse oximetric oxygen saturation at the timepoint of first contact with a physician (EMS physician OR hospital arrival) average 1 hour No
Secondary Quality of emergency care Analysis of the quality of prehospital care on the basis of published guidelines for asthma / COPD. average 1 hour No
Secondary Rate of ventilation Fraction of patients that receive invasive or non-invasive ventilation during the prehospital phase average 1 hour No
Secondary Rate of complications Rate of complications due to medications: allergic reaction, heart rhythm problems 2 hours No
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