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Telemedically Supported Analgesia in the Emergency Medical Service

Primary Purpose

Indication for Analgesia, Emergency Medical Service, Teleconsultation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Teleconsultation
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Indication for Analgesia focused on measuring telemedicine, teleconsultation, analgesia, emergency, prehospital

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Verbal consent obtained or patient is unable to consent due to the severity of the emergency
  • Indication for analgesia

Exclusion Criteria:

  • Refused consent
  • No indication for analgesia

Sites / Locations

  • University Hospital Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Device_ Teleconsultation

Historical Control Period

Arm Description

Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, if patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" with an audio-connection to the EMS team who receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team and can delegate the application of morphine and other analgesics. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The safety, efficacy and the quality of analgesia should be compared with regular EMS.

After completion of the study arm, matched pairs from a historical phase (without the ability of teleconsultation) were searched. Local cases were always matched with comparable controls from the same location.

Outcomes

Primary Outcome Measures

Rate of complications
Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency

Secondary Outcome Measures

Pain level
Pain level measured with numerical rating scale
Incidence of nausea and vomiting
Time intervals
on-scene time, contact to hospital time
Medications and dosages
Evaluation and description of the used medications and dosages

Full Information

First Posted
July 12, 2012
Last Updated
September 21, 2015
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01644032
Brief Title
Telemedically Supported Analgesia in the Emergency Medical Service
Official Title
Telemedically Supported Analgesia in the Emergency Medical Service
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the safety and efficacy of telemedically supported and delegated pain therapy in the Emergency Medical Service (EMS).
Detailed Description
Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team and can delegate the application of morphine and other analgesics. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. All regular ambulances of the five districts are not allowed to administer analgesics without an physician on-scene. They have to call an Advanced Life Support response unit, staffed with an EMS physician, who carries out all kinds of ALS interventions. The safety, efficacy and the quality of analgesia should be compared with regular EMS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indication for Analgesia, Emergency Medical Service, Teleconsultation
Keywords
telemedicine, teleconsultation, analgesia, emergency, prehospital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device_ Teleconsultation
Arm Type
Experimental
Arm Description
Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, if patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" with an audio-connection to the EMS team who receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team and can delegate the application of morphine and other analgesics. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The safety, efficacy and the quality of analgesia should be compared with regular EMS.
Arm Title
Historical Control Period
Arm Type
No Intervention
Arm Description
After completion of the study arm, matched pairs from a historical phase (without the ability of teleconsultation) were searched. Local cases were always matched with comparable controls from the same location.
Intervention Type
Other
Intervention Name(s)
Teleconsultation
Intervention Description
Teleconsultation between paramedics and an EMS physician
Primary Outcome Measure Information:
Title
Rate of complications
Description
Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Pain level
Description
Pain level measured with numerical rating scale
Time Frame
average 1 hour
Title
Incidence of nausea and vomiting
Time Frame
2 hours
Title
Time intervals
Description
on-scene time, contact to hospital time
Time Frame
average 1 hour
Title
Medications and dosages
Description
Evaluation and description of the used medications and dosages
Time Frame
average 1 hour

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Verbal consent obtained or patient is unable to consent due to the severity of the emergency Indication for analgesia Exclusion Criteria: Refused consent No indication for analgesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Rossaint, Prof. Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Department of Anesthesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jörg Brokmann, Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Emergency Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Telemedically Supported Analgesia in the Emergency Medical Service

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