Telemedically Supported Analgesia in the Emergency Medical Service

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01644032
First received: July 12, 2012
Last updated: August 22, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Rate of complications [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency


Secondary Outcome Measures:
  • 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: March 2014
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
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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 22, 2013
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 April 15, 2014