Quality of Telemedically Guided Prehospital Analgesia

Completed

• Conditions: Ambulance; City of Aachen; Adverse Events; Prehospital Emergency Medical Service Physician; Opioids; Analgesia; Prehospital; Telemedicine; Teleconsultation; Tele-emergency Medical Services
• Interventions: Procedure: prehospital analgesia by on-scene EMS physicians; Procedure: physician operated telemedical prehospital analgesia

• Registration Number: NCT02928705
• Lead Sponsor: RWTH Aachen University

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-03
• Study Completion: 2016-06
• Study First Submitted: 2016-07-28
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Study First Posted: 2016-10-10
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
historical control group	prehospital analgesia by on-scene EMS physicians	prehospital analgesia by on-scene EMS physicians
telemedicine group	physician operated telemedical prehospital analgesia	physician operated telemedical prehospital analgesia

Primary Outcome Measures

Name	Time	Method
Quality of analgesia	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.	Decrease of value on the Numerical Rating Scale (NRS; 0-10). The NRS is applied at initial contact with the patient and at the end of the mission.

Secondary Outcome Measures

Name	Time	Method
Administered analgesics and their dosages	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
Rate of adverse events	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.	Respiratory and/or circulatory insufficiency and/or severe allergic reactions
Number of patients with documented analgesia related (safety-) parameters (evaluated for each safety parameter separately)	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.	Documentation of analgesia related parameters: heart rate (beats per minute), blood pressure (mmHg), oxygen saturation (0-100%), respiratory rate (respirations per minute), Glasgow coma scale (Numerical values 3 to 15), The above named parameters should be documented by EMS teams at first medical contact and at patient handover in the emergency room.
Occurrence of nausea and vomiting	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.

Trial Locations

Locations (1)

University Hospital Aachen; 🇩🇪 Aachen, Germany