Quality of Telemedically Guided Prehospital Analgesia

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928705
• Other study ID #: Quality of Tele-Analgesia
• Status: Completed
• Phase: N/A
• First received: July 28, 2016
• Last updated: October 6, 2016
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bezirksregierung Köln, Dezernat 24
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of analgesia	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.	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.	No
Secondary	Rate of adverse events	Respiratory and/or circulatory insufficiency and/or severe allergic reactions	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.	No
Secondary	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.	No
Secondary	Number of patients with documented analgesia related (safety-) parameters (evaluated for each safety parameter separately)	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.	Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.	No
Secondary	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.	No