Clinical trial NCT02928705: Quality of Telemedically Guided Prehospital Analgesia
Official title: Comparison of Analgesic Treatment Quality Between Prehospital Emergency Care of Telemedically Guided Paramedics and On-scene Physicians - a Retrospective Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Prehospital
Telemedicine
Ambulance
Opioids
Teleconsultation
Tele-emergency Medical Services
Adverse Events
City of Aachen
Prehospital Emergency Medical Service Physician
Keywords: analgesia
prehospital
telemedicine
ambulance
opioids
teleconsultation
tele-emergency medical services
adverse events
prehospital emergency medical service physician
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 381
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring prehospital pain treatment in the EMS of the city of Aachen

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.

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

Primary outcomes:
measure: Quality of analgesia
timeFrame: Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
Secondary outcomes:
measure: Rate of adverse events
timeFrame: Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
measure: Administered analgesics and their dosages
timeFrame: Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
measure: Number of patients with documented analgesia related (safety-) parameters (evaluated for each safety parameter separately)
timeFrame: Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
measure: Occurrence of nausea and vomiting
timeFrame: Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
Study officials:
affiliation: University Hospital RWTH Aachen
name: Rolf Rossaint, Professor, MD
role: STUDY_CHAIR
affiliation: University Hospital RWTH Aachen
name: Sebastian Bergrath, MD
role: PRINCIPAL_INVESTIGATOR
References: