Telemedically Supported Analgesia in the Emergency Medical Service

NCT01644032 | Completed

• 2 other identifiers: 005-1003-0034-3PtJ-Az.: z0909im002b
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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).

Conditions

Indication for Analgesia; Emergency Medical Service; Teleconsultation

Keywords

telemedicine; teleconsultation; analgesia; emergency; prehospital

Outcome Measures

Primary Outcomes (1)

• Rate of complications

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

  2 hours

Secondary Outcomes (4)

• Pain level

  average 1 hour

• Incidence of nausea and vomiting

  2 hours

• Time intervals

  average 1 hour

• Medications and dosages

  average 1 hour

Study Arms (2)

Device_ Teleconsultation

EXPERIMENTAL

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

Historical Control Period

NO INTERVENTION

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.

Interventions

Teleconsultation OTHER

Teleconsultation between paramedics and an EMS physician

Device_ Teleconsultation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Verbal consent obtained or patient is unable to consent due to the severity of the emergency
• Indication for analgesia

You may not qualify if:

• Refused consent
• No indication for analgesia

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Agnosia; Emergencies

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Study Officials

• Rolf Rossaint, Prof. Dr.

  University Hospital Aachen, Germany, Department of Anesthesiology

  STUDY CHAIR

• Jörg Brokmann, Dr.

  University Hospital Aachen, Germany, Emergency Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 18, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

DE (1)