AnalgesiaNCT02928705
Quality of Telemedically Guided Prehospital Analgesia
An observational study of Analgesia and Prehospital, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Analgesia, Prehospital, Telemedicine
- What is being tested?
- physician operated telemedical prehospital analgesia and prehospital analgesia by on-scene EMS physicians
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 381 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients requiring prehospital pain treatment in the EMS of the city of Aachen
Who may be able to join
- Initial Numerical Rating Scale ≥ 5 and
- Documented administration of analgesics
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Treatment Quality Between Prehospital Emergency Care of Telemedically Guided Paramedics and On-scene Physicians - a Retrospective Longitudinal Study
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.
Read the 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.
- Conditions
- Analgesia, Prehospital, Telemedicine, Ambulance, Opioids, Teleconsultation
- Being tested
- physician operated telemedical prehospital analgesia, prehospital analgesia by on-scene EMS physicians
- Keywords
- analgesia, prehospital, telemedicine, ambulance, opioids, teleconsultation, tele-emergency medical services, adverse events, prehospital emergency medical service physician
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physician operated telemedical prehospital analgesiaProcedure or surgery
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 physiciansProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| telemedicine group | physician operated telemedical prehospital analgesia Receives: Procedure: physician operated telemedical prehospital analgesia | |
| historical control group | prehospital analgesia by on-scene EMS physicians Receives: Procedure: prehospital analgesia by on-scene EMS physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Respiratory and/or circulatory insufficiency and/or severe allergic reactions
Measured: 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
Measured: 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)
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.
Measured: 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
Measured: Time span of the respective prehospital emergency case treatment; on average a time interval of 30 - 120 minutes for each case.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolf Rossaint, Professor, MD, Study chair, University Hospital, AachenSebastian Bergrath, MD, Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928705
- Sponsor's protocol ID
- Quality of Tele-Analgesia
- Status last verified
- Oct 2016
- First submitted
- 28 Jul 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No additional research benefits.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Treatment Quality Between Prehospital Emergency Care of Telemedically Guided Paramedics and On-scene Physicians - a Retrospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT02928705
- Acronym / sponsor ID
- Quality of Tele-Analgesia
- Conditions
- Analgesia, Prehospital, Telemedicine, Ambulance, Opioids, Teleconsultation
- Keywords
- analgesia, prehospital, telemedicine, ambulance, opioids, teleconsultation, tele-emergency medical services, adverse events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemedicine group | – | Procedure: physician operated telemedical prehospital analgesiaphysician operated telemedical prehospital analgesia |
| historical control group | – | Procedure: prehospital analgesia by on-scene EMS physiciansprehospital analgesia by on-scene EMS physicians |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients requiring prehospital pain treatment in the EMS of the city of Aachen
Key inclusion criteria (2 listed)
- Initial Numerical Rating Scale ≥ 5 and
- Documented administration of analgesics
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physician operated telemedical prehospital analgesiaAmbulances 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. | Procedure or surgery | telemedicine group |
| prehospital analgesia by on-scene EMS physiciansThis (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. | Procedure or surgery | historical control group |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Individual participant dataSharing planned: No. No additional research benefits.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Rossaint, Professor, MD study chair
University Hospital, Aachen
Sebastian Bergrath, MD principal investigator
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia and Prehospital, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.