Quality of Telemedically Guided Prehospital Analgesia

NCT02928705 | Completed

• 1 other identifier: Quality of Tele-Analgesia
• Study Type: observational
• Target: 381
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

telemedicine group

physician operated telemedical prehospital analgesia

Procedure: physician operated telemedical prehospital analgesia

historical control group

prehospital analgesia by on-scene EMS physicians

Procedure: prehospital analgesia by on-scene EMS physicians

Interventions

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.

telemedicine group

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.

historical control group

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients requiring prehospital pain treatment in the EMS of the city of Aachen

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rolf Rossaint, Professor, MD

  University Hospital, Aachen

  STUDY CHAIR

• Sebastian Bergrath, MD

  University Hospital, Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: October 10, 2016
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 10, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)