Telemedically Supported Analgesia in the Emergency Medical Service

Emergency Medical Service Clinical Trial

Official title:

Telemedically Supported Analgesia in the Emergency Medical Service

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644032
• Other study ID #: 005-1003-0034-3
• Secondary ID: PtJ-Az.: z0909im
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: September 21, 2015
• Start date: August 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: September 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Emergency Medical Service
• Indication for Analgesia
• Teleconsultation

Intervention

Other:
• Teleconsultation
Teleconsultation between paramedics and an EMS physician

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complications	Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency	2 hours	No
Secondary	Pain level	Pain level measured with numerical rating scale	average 1 hour	No
Secondary	Incidence of nausea and vomiting		2 hours	No
Secondary	Time intervals	on-scene time, contact to hospital time	average 1 hour	No
Secondary	Medications and dosages	Evaluation and description of the used medications and dosages	average 1 hour	No