Telemedically Supported Analgesia in the Emergency Medical Service

Not Applicable

Completed

• Conditions: Teleconsultation; Emergency Medical Service; Indication for Analgesia
• Interventions: Other: Teleconsultation

• Registration Number: NCT01644032
• Lead Sponsor: RWTH Aachen University

Brief Summary

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).

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 Timeline

• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Study Start: 2012-08
• Primary Completion: 2013-07
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device_ Teleconsultation	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.

Primary Outcome Measures

Name	Time	Method
Rate of complications	2 hours	Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Aachen; 🇩🇪 Aachen, Germany