TelemedicineNCT02090452
Mobile Transmission of Prehospital Vital Signs to the Emergency Department
A study testing Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB Sweden in people with Telemedicine and Triage, run by University of Aarhus at 3 sites in Denmark.
Trial summary
The purpose of this study is to examine if real time transmission of vital signs, ECG and chat communication between the prehospital ambulances and the emergency department has an effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to treatment and time to diagnostics Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Telemedicine, Triage, Emergency Medical Service
- What is being tested?
- Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB Sweden
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesDenmark
- Study dates
- Jun 2013to Mar 2014
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients transported with ambulance to the emergency department
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Prehospital Emergency Medical Services, Aarhus, Central Denmark Region
Aarhus N, 8200
Horsens Regional Hospital, Central Region Denmark
Horsens, 8700
Responce A/S
Horsens, 8700
About this study
Official title: Telemedical Solutions in Medical Emergencies, Advantages and Disadvantages for Patients, Healthcare Professionals, and the Healthcare System: Study 1: "Mobile Transmission of Prehospital Vital Signs to the Emergency Department - Effect on Patient Outcomes, Treatment and Diagnosis"
The purpose of this study is to examine if real time transmission of vital signs, ECG and chat communication between the prehospital ambulances and the emergency department has an effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to treatment and time to diagnostics
- Conditions
- Telemedicine, Triage, Emergency Medical Service
- Being tested
- Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB Sweden
- Keywords
- Telemedicine, Mobile, Vital signs, Prehospital care, Emergency medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB SwedenDevice
Also called Vital signs, ECG and Chat-messaging delivered real time from prehospital ambulances to the receiving emergency dept.
| Study group | Role | What they receive |
|---|---|---|
| Transmission of vital signs, ecg, chat | Experimental | Data from patients transported in ambulances with equipment which enables real time transmission of vital signs, ecg and chat from ambulances to the emergency department. Receives: Device: Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB Sweden |
| No transmission of data | No intervention | Patient transported with conventional ambulances without the possibility to transmit real time patient related data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to physician
Time from the patient arrival registered in the patients' logistics system (Cetrea) to registered first patient/physician contact registered in the same patients logistics system.
Measured: Time from arrival to first patient-physician contact, assessed up to 36 months
Secondary outcomes (5)
All cause mortality
Measured: 30 days, assessed up to 36 months
Time to treatment
Time from the patient arrival registered in the patients' logistics system (Cetrea) to first administered iv antibiotics registered in the patient's hospital record
Measured: Time from arrival to administration of first iv. antibiotics, assessed up to 36 months
Time to x-ray
Time from the patient arrival registered in the patients' logistics system (Cetrea) to completion of x-ray requisition form registered in the radiologic logistics system (Kodak RIS, 2010 edition)
Measured: Time form arrival at the emergency department to completion of x-ray requisition form, assessed up to 36 months
Time to ICU
Time from the patient arrival registered in the patients' logistics system (Cetrea) to time of admission to the ICU registered in the patient's hospital record. .
Measured: Time from arrival to admission to the ICU, assessed up to 36 months
Number of ICU admissions
Measured: During present hospitalization, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Central Denmark Region
- Responsible party
- Principal investigator, Nikolaj Raaber, University of Aarhus
- Investigators
- Erika F. Christensen, MD, Medical director, Study director, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090452
- Sponsor's protocol ID
- NRAA
- Status last verified
- Apr 2014
- First submitted
- 20 Feb 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedical Solutions in Medical Emergencies, Advantages and Disadvantages for Patients, Healthcare Professionals, and the Healthcare System: Study 1: "Mobile Transmission of Prehospital Vital Signs to the Emergency Department - Effect on Patient Outcomes, Treatment and Diagnosis"
- ClinicalTrials.gov ID
- NCT02090452
- Acronym / sponsor ID
- NRAA
- Conditions
- Telemedicine, Triage, Emergency Medical Service
- Keywords
- Telemedicine, Mobile, Vital signs, Prehospital care, Emergency medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Central Denmark Region
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Mar 2014 (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 study is to examine if real time transmission of vital signs, ECG and chat communication between the prehospital ambulances and the emergency department has an effect on patient mortality, ICU admission, hospitalization time, time to doctor, time to treatment and time to diagnostics
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transmission of vital signs, ecg, chat | Experimental | Device: Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB SwedenData from patients transported in ambulances with equipment which enables real time transmission of vital signs, ecg and chat from ambulances to the emergency department. |
| No transmission of data | No intervention | –Patient transported with conventional ambulances without the possibility to transmit real time patient related data. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients transported with ambulance to the emergency department
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB SwedenAlso: Vital signs, ECG and Chat-messaging delivered real time from prehospital ambulances to the receiving emergency dept. | Device | Transmission of vital signs, ecg, chat |
Primary outcome
Time to physician
Time frame: Time from arrival to first patient-physician contact, assessed up to 36 months
Time from the patient arrival registered in the patients' logistics system (Cetrea) to registered first patient/physician contact registered in the same patients logistics system.
5 secondary outcomes
All cause mortality
Time frame: 30 days, assessed up to 36 months
Time to treatment
Time frame: Time from arrival to administration of first iv. antibiotics, assessed up to 36 months
Time to x-ray
Time frame: Time form arrival at the emergency department to completion of x-ray requisition form, assessed up to 36 months
Time to ICU
Time frame: Time from arrival to admission to the ICU, assessed up to 36 months
Number of ICU admissions
Time frame: During present hospitalization, assessed up to 36 months
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 24 Apr 2014.
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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.
Erika F. Christensen, MD, Medical director study director
Central Denmark Region
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB Sweden in people with Telemedicine and Triage, run by University of Aarhus at 3 sites in Denmark.
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 1 inclusion and 1 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 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Time to physician (time frame: Time from arrival to first patient-physician contact, assessed up to 36 months). 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 24 Apr 2014.