Telemedically Supported Analgesia in the Emergency Medical Service
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Purpose
The aim of the study is to evaluate the safety and efficacy of telemedically supported and delegated pain therapy in the Emergency Medical Service (EMS).
| Condition | Intervention |
|---|---|
|
Indication for Analgesia Emergency Medical Service Teleconsultation |
Other: Teleconsultation |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Telemedically Supported Analgesia in the Emergency Medical Service |
- Rate of complications [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency
- Pain level [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]Pain level measured with numerical rating scale
- Incidence of nausea and vomiting [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Time intervals [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]on-scene time, contact to hospital time
- Medications and dosages [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]Evaluation and description of the used medications and dosages
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Device_ Teleconsultation
Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, 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. 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 and can delegate the application of morphine and other analgesics. 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, efficacy and the quality of analgesia should be compared with regular EMS. |
Other: Teleconsultation
Teleconsultation between paramedics and an EMS physician
|
Detailed Description:
Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, 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. 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 and can delegate the application of morphine and other analgesics. 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.
All regular ambulances of the five districts are not allowed to administer analgesics without an physician on-scene. They have to call an Advanced Life Support response unit, staffed with an EMS physician, who carries out all kinds of ALS interventions.
The safety, efficacy and the quality of analgesia should be compared with regular EMS.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Verbal consent obtained or patient is unable to consent due to the severity of the emergency
- Indication for analgesia
Exclusion Criteria:
- Refused consent
- No indication for analgesia
Contacts and Locations| Contact: Rolf Rossaint, Prof. Dr. | +49-241-8088179 | anaesthesiologie@ukaachen.de |
| Germany | |
| University Hospital Aachen | Recruiting |
| Aachen, Germany, 52074 | |
| Contact: Jörg Brokmann, Dr. +49-241-8088421 notaufnahme@ukaachen.de | |
| Study Chair: | Rolf Rossaint, Prof. Dr. | University Hospital Aachen, Germany, Department of Anesthesiology |
| Principal Investigator: | Jörg Brokmann, Dr. | University Hospital Aachen, Germany, Emergency Department |
More Information
No publications provided
| Responsible Party: | RWTH Aachen University |
| ClinicalTrials.gov Identifier: | NCT01644032 History of Changes |
| Other Study ID Numbers: | 005-1003-0034-3, PtJ-Az.: z0909im002b |
| Study First Received: | July 12, 2012 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by RWTH Aachen University:
|
telemedicine teleconsultation analgesia emergency prehospital |
Additional relevant MeSH terms:
|
Emergencies Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013