- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644045
Prehospital Emergency Care of Obstructive Respiratory Emergencies With the Use of Teleconsultation
September 21, 2015 updated by: RWTH Aachen University
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aachen, Germany, 52074
- University Hospital Aachen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device: Teleconsultation
In cases of acute obstructive, respiratory emergencies if patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" who 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.
|
Teleconsultation for the EMS in acute respiratory emergencies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen Saturation
Time Frame: average 1 hour
|
Measurement of pulse oximetric oxygen saturation at the timepoint of first contact with a physician (EMS physician OR hospital arrival)
|
average 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of emergency care
Time Frame: average 1 hour
|
Analysis of the quality of prehospital care on the basis of published guidelines for asthma / COPD.
|
average 1 hour
|
Rate of ventilation
Time Frame: average 1 hour
|
Fraction of patients that receive invasive or non-invasive ventilation during the prehospital phase
|
average 1 hour
|
Rate of complications
Time Frame: 2 hours
|
Rate of complications due to medications: allergic reaction, heart rhythm problems
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
July 12, 2012
First Submitted That Met QC Criteria
July 16, 2012
First Posted (Estimate)
July 18, 2012
Study Record Updates
Last Update Posted (Estimate)
September 22, 2015
Last Update Submitted That Met QC Criteria
September 21, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 005-1003-0034-4
- PtJ-Az.: z0909im002b (Other Grant/Funding Number: PTJ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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