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Completed

NCT Number: NCT01644032

Telemedically Supported Analgesia in the Emergency Medical Service

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).

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Key information

Conditions

Indication for Analgesia Agnosia Disease Attributes Emergencies Emergency Medical Service Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Teleconsultation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Aachen

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teleconsultation

Other

Teleconsultation between paramedics and an EMS physician

Primary outcomes

  1. Rate of complications

    Time frame: 2 hours

    Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency

Secondary outcomes

  1. Pain level

    Time frame: average 1 hour

    Pain level measured with numerical rating scale

  2. Incidence of nausea and vomiting

    Time frame: 2 hours

  3. Time intervals

    Time frame: average 1 hour

    on-scene time, contact to hospital time

  4. Medications and dosages

    Time frame: average 1 hour

    Evaluation and description of the used medications and dosages

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Jul 18, 2012
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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