Telemedically Supported Analgesia in the Emergency Medical Service

September 21, 2015 updated by: RWTH Aachen University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

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

  • Germany
      • 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications
Time Frame: 2 hours
Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: average 1 hour
Pain level measured with numerical rating scale
average 1 hour
Incidence of nausea and vomiting
Time Frame: 2 hours
2 hours
Time intervals
Time Frame: average 1 hour
on-scene time, contact to hospital time
average 1 hour
Medications and dosages
Time Frame: average 1 hour
Evaluation and description of the used medications and dosages
average 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Jörg Brokmann, Dr., University Hospital Aachen, Germany, Emergency Department

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005-1003-0034-3
  • 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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