TelemedicineNCT05388071
Feasibility of Telemedicine Under Ambulance Station Conditions
An observational study of Telemedicine and Disaster Medicine, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Our aim is to evaluate the feasibility of telemedicine in context of medical service in an ambulance station and in a further step in context of civil defense situations. The conditions in those situations are different to the usual usage of telemedicine in context of emergency medical services (EMS) like the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telemedicine, Disaster Medicine, Emergency Medicine
- What is being tested?
- Usage of telemedicine and tele-consultation for treatment
- How many people
- 404 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2022to 6 Jun 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We assume a cohort out of the total of festival visitors which is composed of 16-40 years old people with occasional older visitors. The patient-collective can be composed of intoxications by alcohol or drugs and minor violations of the extremities. Effects of heat and light can occur as well. Only those who consent to our study can be part of it, therefore every patient has to give his or her consent to the evaluation of the already bespoken outcome measures and data acquisition.
Who may be able to join
- full legal age
- capacity to consent
Who cannot join
- apnea
- acute failure of breathing
- cardiac arrest
- STEMI
- unconsciousness
- status epilepticus
Show all 20Show fewer
- life-threatening arrhythmia
- polytrauma
- non-manageable symptoms of a mental illness, self-endangerment, danger to others
- imminent birth
- serious traffic accident or traffic accident with children involved
- fall from a great height (>3m)
- gunshot or knife wounds to the head, neck or torso
- fire with personal damage
- high-voltage accident
- water accidents (drowning, swimming accidents, breaking in the ice)
- accidents with involvement of hazardous substances
- killing spree, hostage situations or other situations which endanger the lives of the medical personnel
- imminent threat of suizide
- non-consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: The Tele-senior EMS Physician as a Strategy for the Future of Disaster Medicine - a Study Testing the Feasibility of Telemedicine in Civil Defense: Feasibility of Telemedicine Under Ambulance Station Conditions
Our aim is to evaluate the feasibility of telemedicine in context of medical service in an ambulance station and in a further step in context of civil defense situations.
The conditions in those situations are different to the usual usage of telemedicine in context of emergency medical services (EMS) like the "Telenotarzt" in Aachen. The medical personnel who are performing the medical treatment in ambulance stations or civil defense situations are most volunteers and are ordinarily not as experienced and educated as professional medical personnel in EMS. In case of civil defense situations, the personnel also must deal with shortage in material which we are not going to simulate in our study.
Read more
The study will be realized at each one ambulance station at four large-scale events. Every time there will be a telemedicine workspace with an EMS-physician educated in telemedicine who can be contacted by briefed and equipped medical personnel according to the "TeleSAN"-standard. The emergency personnel start the patient's treatment according to their known standards and decide on their own whether they want to contact the tele-EMS-physician or not.
Before starting the tele-consultation, every patient must declare his consent to the tele-consultation, otherwise tele-consultation cannot be realized, and the patient needs to be treated according to common standards.
Due to spatial proximity of the telemedicine workspace and the ambulance station, the tele-EMS-physician can also work as an EMS-physician in the ambulance station if necessary.
As a hypothesis we declare that telemedicine is feasible in context of an ambulance station. To evaluate the feasibility, we use patient's medical protocols, observations and surveys.
Read the detailed description
To evaluate the feasibility of telemedicine in context of an ambulance station with all the given restrictions compared to usage of telemedicine in emergency medical services (EMS), we will set up each one ambulance station at four large-scale events in Germany with a telemedicine infrastructure. The ambulance stations at such events are the primary place to go for visitors to get a primary medical care and is also used as a primary place for the patients of medical service providers on feet.
As part of the telemedicine infrastructure, educated personnel is required. The study protocol defines that any medical personnel with the ability to use telemedicine must be declared as a "Rettungssanitäter/in", a special paramedic qualification in Germany comparable to an EMT-I/85 (Intermediate) in the USA. These emergency personnel are called "TeleSAN".
Before the assignment in the ambulance station starts, every TeleSAN will be educated and briefed in the usage of the telemedical devices. The used equipment has been evaluated in context of the research project "TeleSAN" at the AcuteCare InnovationHub, University Hospital Aachen, Germany and is composed of a smartphone with a TeleSAN-app, a headset, and a camera. In addition to that, every TeleSAN in the ambulance station will be equipped with a Bluetooth-medical-device-set consisting of a mini-ECG, a blood glucose meter, a blood pressure cuff and a bluetooth-stethoscope which can stream all data in real-time to the tele-EMS-physician.
To stream the data and as a communication platform, the "TeleDoc"-App for video-consultation and the "TeleSAN"-App which is based on the "TeleDoc"-App with a focus on disaster medicine, both developed by Docs in Clouds TeleCare GmbH, Aachen, Germany, will be used.
Every patient who enters the ambulance station will be informed that a telemedicine-study is going on. In addition to that, the protocol defines a separate enlightenment for every patient who will be treated by telemedicine through the TeleSAN-operator before the teleconsultation starts.
Whether telemedicine will be used for patient's treatment or not is at the discretion of the TeleSAN, who will always start the treatment on his / her own and evaluates if the patient meets any exclusion criteria which would lead to not-usage of telemedicine.
In case of a none-given consent or in case of medical or technical necessity of termination of the teleconsultation, the tele-EMS-physician can work as a regular EMS-physician in the ambulance station thanks to spatial proximity. Therefore, we can guarantee a treatment according to the current medical standards all the time. In addition to the already listed medical devices, we will also have a defibrillator/ECG-monitor, a ventilator and a suction pump available for emergency situations.
The aim is to evaluate if telemedicine is feasible in context of an ambulance station regarding medical protocols, observations, and surveys.
In a further step an assessment of a possible usage of telemedicine in context of civil defense situations will be done.
- Conditions
- Telemedicine, Disaster Medicine, Emergency Medicine
- Being tested
- Usage of telemedicine and tele-consultation for treatment
- Keywords
- TeleSAN, Telemedicine, Remote Consultation, Remote Treatment, Emergency Medical Services, Disaster Medicine, Emergency Medicine, Teleconsultation, Tele-emergency physician, Quality of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usage of telemedicine and tele-consultation for treatmentOther
Telemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Treatment with the aid of telemedicine | Telemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible. Receives: Other: Usage of telemedicine and tele-consultation for treatment | |
| No intervention: Usual treatment | Treatment will be performed as usual without the usage of telemedicine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of triage category using the German PRIOR algorithm (Primäres Ranking zur initialen Orientierung im Rettungsdienst)
Changes of the patient's medical condition will be measured using the german PRIOR algorithm which is used to triage patients in three categories: red, yellow and green. A change of triage category from red to yellow/green or from yellow to green means a better outcome, a change from green to yellow/red means a worse outcome.
Measured: through study completion, in total estimated 1 year
Improvement of vital signs
Changes of the patient's medical condition will be measured by analyzing changes in the patient's vital signs. Changes from unphysiological to physiological vital signs mean a better outcome.
Measured: through study completion, in total estimated 1 year
Improvement of NACA-Score (National Advisory Committee for Aeronautics)
Changes of the patient's medical condition will be measured using the NACA-Score. Changes from a lower to a higher score means a worse outcome.
Measured: through study completion, in total estimated 1 years
Secondary outcomes (1)
Usability of the telemedicine-devices and infrastructure and their reliable function
By analyzation of observation protocols, patient-surveys and personnel-surveys, the usability and the reliability can be evaluated
Measured: through study completion, in total estimated 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Jul 2022
- Primary completion3 Jul 2022
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Müller, RWTH Aachen University
- Investigators
- Rolf Rossaint, Prof. Dr., Study chair, University Hospital RWTH Aachen, Germany, Anaesthesiology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388071
- Sponsor's protocol ID
- 22-130
- Other IDs
- Notice No. 03/2019
- Status last verified
- Sep 2023
- First submitted
- 11 May 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tele-senior EMS Physician as a Strategy for the Future of Disaster Medicine - a Study Testing the Feasibility of Telemedicine in Civil Defense: Feasibility of Telemedicine Under Ambulance Station Conditions
- ClinicalTrials.gov ID
- NCT05388071
- Acronym / sponsor ID
- 22-130
- Conditions
- Telemedicine, Disaster Medicine, Emergency Medicine
- Keywords
- TeleSAN, Telemedicine, Remote Consultation, Remote Treatment, Emergency Medical Services, Disaster Medicine, Emergency Medicine, Teleconsultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 3 Jul 2022 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 24 May 2022 (actual)
- 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.
Our aim is to evaluate the feasibility of telemedicine in context of medical service in an ambulance station and in a further step in context of civil defense situations.
The conditions in those situations are different to the usual usage of telemedicine in context of emergency medical services (EMS) like the "Telenotarzt" in Aachen. The medical personnel who are performing the medical treatment in ambulance stations or civil defense situations are most volunteers and are ordinarily not as experienced and educated as professional medical personnel in EMS. In case of civil defense situations, the personnel also must deal with shortage in material which we are not going to simulate in our study.
The study will be realized at each one ambulance station at four large-scale events. Every time there will be a telemedicine workspace with an EMS-physician educated in telemedicine who can be contacted by briefed and equipped medical personnel according to the "TeleSAN"-standard. The emergency personnel start the patient's treatment according to their known standards and decide on their own whether they want to contact the tele-EMS-physician or not.
Before starting the tele-consultation, every patient must declare his consent to the tele-consultation, otherwise tele-consultation cannot be realized, and the patient needs to be treated according to common standards.
Due to spatial proximity of the telemedicine workspace and the ambulance station, the tele-EMS-physician can also work as an EMS-physician in the ambulance station if necessary.
As a hypothesis we declare that telemedicine is feasible in context of an ambulance station. To evaluate the feasibility, we use patient's medical protocols, observations and surveys.
Detailed description
To evaluate the feasibility of telemedicine in context of an ambulance station with all the given restrictions compared to usage of telemedicine in emergency medical services (EMS), we will set up each one ambulance station at four large-scale events in Germany with a telemedicine infrastructure. The ambulance stations at such events are the primary place to go for visitors to get a primary medical care and is also used as a primary place for the patients of medical service providers on feet.
As part of the telemedicine infrastructure, educated personnel is required. The study protocol defines that any medical personnel with the ability to use telemedicine must be declared as a "Rettungssanitäter/in", a special paramedic qualification in Germany comparable to an EMT-I/85 (Intermediate) in the USA. These emergency personnel are called "TeleSAN".
Before the assignment in the ambulance station starts, every TeleSAN will be educated and briefed in the usage of the telemedical devices. The used equipment has been evaluated in context of the research project "TeleSAN" at the AcuteCare InnovationHub, University Hospital Aachen, Germany and is composed of a smartphone with a TeleSAN-app, a headset, and a camera. In addition to that, every TeleSAN in the ambulance station will be equipped with a Bluetooth-medical-device-set consisting of a mini-ECG, a blood glucose meter, a blood pressure cuff and a bluetooth-stethoscope which can stream all data in real-time to the tele-EMS-physician.
To stream the data and as a communication platform, the "TeleDoc"-App for video-consultation and the "TeleSAN"-App which is based on the "TeleDoc"-App with a focus on disaster medicine, both developed by Docs in Clouds TeleCare GmbH, Aachen, Germany, will be used.
Every patient who enters the ambulance station will be informed that a telemedicine-study is going on. In addition to that, the protocol defines a separate enlightenment for every patient who will be treated by telemedicine through the TeleSAN-operator before the teleconsultation starts.
Whether telemedicine will be used for patient's treatment or not is at the discretion of the TeleSAN, who will always start the treatment on his / her own and evaluates if the patient meets any exclusion criteria which would lead to not-usage of telemedicine.
In case of a none-given consent or in case of medical or technical necessity of termination of the teleconsultation, the tele-EMS-physician can work as a regular EMS-physician in the ambulance station thanks to spatial proximity. Therefore, we can guarantee a treatment according to the current medical standards all the time. In addition to the already listed medical devices, we will also have a defibrillator/ECG-monitor, a ventilator and a suction pump available for emergency situations.
The aim is to evaluate if telemedicine is feasible in context of an ambulance station regarding medical protocols, observations, and surveys.
In a further step an assessment of a possible usage of telemedicine in context of civil defense situations will be done.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Treatment with the aid of telemedicine | – | Other: Usage of telemedicine and tele-consultation for treatmentTelemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible. |
| No intervention: Usual treatment | – | –Treatment will be performed as usual without the usage of telemedicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We assume a cohort out of the total of festival visitors which is composed of 16-40 years old people with occasional older visitors. The patient-collective can be composed of intoxications by alcohol or drugs and minor violations of the extremities. Effects of heat and light can occur as well. Only those who consent to our study can be part of it, therefore every patient has to give his or her consent to the evaluation of the already bespoken outcome measures and data acquisition.
Key inclusion criteria (2 listed)
- full legal age
- capacity to consent
Key exclusion criteria (20 listed)
- apnea
- acute failure of breathing
- cardiac arrest
- STEMI
- unconsciousness
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 |
|---|---|---|
| Usage of telemedicine and tele-consultation for treatmentTelemedicine will be used to treat patients at an ambulance station. The medical interventions will be performed by a TeleSAN after delegation through a tele-EMS-physician if possible. | Other | Intervention: Treatment with the aid of telemedicine |
Primary outcome
Change of triage category using the German PRIOR algorithm (Primäres Ranking zur initialen Orientierung im Rettungsdienst)
Time frame: through study completion, in total estimated 1 year
Changes of the patient's medical condition will be measured using the german PRIOR algorithm which is used to triage patients in three categories: red, yellow and green. A change of triage category from red to yellow/green or from yellow to green means a better outcome, a change from green to yellow/red means a worse outcome.
Improvement of vital signs
Time frame: through study completion, in total estimated 1 year
Changes of the patient's medical condition will be measured by analyzing changes in the patient's vital signs. Changes from unphysiological to physiological vital signs mean a better outcome.
Improvement of NACA-Score (National Advisory Committee for Aeronautics)
Time frame: through study completion, in total estimated 1 years
Changes of the patient's medical condition will be measured using the NACA-Score. Changes from a lower to a higher score means a worse outcome.
1 secondary outcome
Usability of the telemedicine-devices and infrastructure and their reliable function
Time frame: through study completion, in total estimated 1 year
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 8 Sep 2023.
- project page with additional information presented for lay peopleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, Prof. Dr. study chair
University Hospital RWTH Aachen, Germany, Anaesthesiology Clinic
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 Telemedicine and Disaster Medicine, 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 20 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 8 Sep 2023. 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?
Change of triage category using the German PRIOR algorithm (Primäres Ranking zur initialen Orientierung im Rettungsdienst) (time frame: through study completion, in total estimated 1 year). The study lists 3 primary outcomes in all. 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 8 Sep 2023.