Quality of Telemedically Guided Prehospital Analgesia

NCT ID: NCT02928705

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 381 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-06-30

Brief Summary

The purpose of this retrospective study is to analyze quality and adverse events of analgesia by telemedically supported paramedics in comparison to conventional treatment by on-scene emergency medical service (EMS) physicians in the EMS of the city of Aachen, Germany.

Detailed Description

The standard emergency medical service (EMS) in Germany consists of a two-tiered system with ambulances (paramedics) and prehospital EMS physician units. For example, legal conditions restrict opioid-based analgesia to physicians. Based on pre-defined standards regional emergency dispatch centers deploy both kinds of emergency units.

In recent years telemedicine emerged as a complementary system in EMS that may provide remote medical expertise and sustain or even improve quality of medical treatment on-scene. Particularly, based on the results of the projects Med-on-@ix and TemRas (telemedical rescue assistance system), emergency telemedical services were gradually implemented in daily routine of the EMS of the city of Aachen, Germany.

In this retrospective study the quality and adverse events of analgesia by telemedically supported paramedics shall be compared to conventional treatment by on-scene EMS physicians in the EMS of the city of Aachen, Germany.

Conditions

Analgesia; Prehospital; Telemedicine; Ambulance; Opioids; Teleconsultation; Tele-emergency Medical Services; Adverse Events; City of Aachen; Prehospital Emergency Medical Service Physician

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

telemedicine group

physician operated telemedical prehospital analgesia

physician operated telemedical prehospital analgesia

Intervention Type: PROCEDURE

Ambulances in the EMS of the city of Aachen are equipped with a portable telemedicine system. In emergencies requiring intravenous analgesia paramedics can use this system to contact the tele-EMS physician with an audio-connection. Vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) can be transferred in real-time. The transmission of still pictures - taken with an official smartphone - and video streaming from the inside of the ambulance are also possible. The tele-EMS physician supports the paramedics and can delegate the application of morphine and other analgesics based on two predefined algorithms for trauma and non-trauma cases that are displayed on a context-sensitive telemedical documentation system in the teleconsultation center.

historical control group

prehospital analgesia by on-scene EMS physicians

prehospital analgesia by on-scene EMS physicians

Intervention Type: PROCEDURE

This (control) group represents the conventional treatment in German emergency medical service (EMS). In addition to an ambulance manned with paramedics, a prehospital EMS physician is deployed to conduct analgesic treatment on-scene. Treatment data for this group are selected from the time period before implementing teleconsultation in routine and therefore represent a historical control group.

Interventions

physician operated telemedical prehospital analgesia

Ambulances in the EMS of the city of Aachen are equipped with a portable telemedicine system. In emergencies requiring intravenous analgesia paramedics can use this system to contact the tele-EMS physician with an audio-connection. Vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) can be transferred in real-time. The transmission of still pictures - taken with an official smartphone - and video streaming from the inside of the ambulance are also possible. The tele-EMS physician supports the paramedics and can delegate the application of morphine and other analgesics based on two predefined algorithms for trauma and non-trauma cases that are displayed on a context-sensitive telemedical documentation system in the teleconsultation center.

Intervention Type: PROCEDURE

prehospital analgesia by on-scene EMS physicians

This (control) group represents the conventional treatment in German emergency medical service (EMS). In addition to an ambulance manned with paramedics, a prehospital EMS physician is deployed to conduct analgesic treatment on-scene. Treatment data for this group are selected from the time period before implementing teleconsultation in routine and therefore represent a historical control group.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Initial Numerical Rating Scale ≥ 5 and
• Documented administration of analgesics

Exclusion Criteria

• Missing consent for telemedical consultation (in teleconsultation group)
• Initial NRS < 5
• Analgesia in non-ST-segment elevation acute coronary syndrome (Non-STEMI-ACS) and ST-elevating myocardial infarction (STEMI)
• Initially unconscious patient
• Inter-hospital transfer missions
• Cases involving both on-scene and telemedical-EMS physicians

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolf Rossaint, Professor, MD

Role: STUDY_CHAIR

University Hospital, Aachen

Sebastian Bergrath, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Aachen

Locations

University Hospital Aachen

Aachen, , Germany

Countries

Germany

Other Identifiers

Quality of Tele-Analgesia

Identifier Type: -

Identifier Source: org_study_id