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Telemedically Supported Analgesia in the Emergency Medical Service

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01644032
First Posted: July 18, 2012
Last Update Posted: September 22, 2015
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.
Information provided by (Responsible Party):
RWTH Aachen University
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telemedically Supported Analgesia in the Emergency Medical Service

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Rate of complications [ Time Frame: 2 hours ]
    Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency


Secondary Outcome Measures:
  • Pain level [ Time Frame: average 1 hour ]
    Pain level measured with numerical rating scale

  • Incidence of nausea and vomiting [ Time Frame: 2 hours ]
  • Time intervals [ Time Frame: average 1 hour ]
    on-scene time, contact to hospital time

  • Medications and dosages [ Time Frame: average 1 hour ]
    Evaluation and description of the used medications and dosages


Enrollment: 106
Study Start Date: August 2012
Study Completion Date: September 2015
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
No Intervention: Historical Control Period
After completion of the study arm, matched pairs from a historical phase (without the ability of teleconsultation) were searched. Local cases were always matched with comparable controls from the same location.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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): NCT01644032


Locations
Germany
University Hospital Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01644032     History of Changes
Other Study ID Numbers: 005-1003-0034-3
PtJ-Az.: z0909im002b ( Other Grant/Funding Number: PTJ )
First Submitted: July 12, 2012
First Posted: July 18, 2012
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by RWTH Aachen University:
telemedicine
teleconsultation
analgesia
emergency
prehospital

Additional relevant MeSH terms:
Emergencies
Agnosia
Disease Attributes
Pathologic Processes
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms