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Completed

NCT Number: NCT02928705

Quality of Telemedically Guided Prehospital Analgesia

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.

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Key information

Conditions

Analgesia Adverse Events Agnosia Ambulance City of Aachen Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioids Pathological Conditions, Signs and Symptoms Perceptual Disorders Prehospital Prehospital Emergency Medical Service Physician Signs and Symptoms Tele-emergency Medical Services Teleconsultation Telemedicine

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Aachen

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physician operated telemedical prehospital analgesia

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.

prehospital analgesia by on-scene EMS physicians

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.

Primary outcomes

  1. Quality of analgesia

    Time frame: 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 outcomes

  1. Rate of adverse events

    Time frame: 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

  2. Administered analgesics and their dosages

    Time frame: Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.

  3. Number of patients with documented analgesia related (safety-) parameters (evaluated for each safety parameter separately)

    Time frame: 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.

  4. Occurrence of nausea and vomiting

    Time frame: Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Comparison of Analgesic Treatment Quality Between Prehospital Emergency Care of Telemedically Guided Paramedics and On-scene Physicians - a Retrospective Longitudinal Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 10, 2016
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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