Cardiac ArrestNCT03654846
Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept
A study testing EmergencyEye in people with Cardiac Arrest, run by University of Cologne at 1 site in Germany.
Trial summary
Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- EmergencyEye
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 25 Aug 2018to 30 Sep 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- cardiovascular diseases
- pulmonary diseases
- pregnancy
- all other conditions that make CPR impossible
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
Cologne
About this study
Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service.
In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable.
This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.
Read the detailed description
Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service.
In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable, and automated localisation of the caller.
This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.
- Conditions
- Cardiac Arrest
- Being tested
- EmergencyEye
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmergencyEyeDevice
EmergencyEye Smartphone App
| Study group | Role | What they receive |
|---|---|---|
| Conventional emergency call | No intervention | Emergency call with conventinal cell phone: * verbal description of location * telephone-assisted CPR |
| EmergencyEye emergency call | Experimental | Emergency call with EmergencyEye App on cell phone:
* automated geolocalisation
* video-assisted CPR Receives: Device: EmergencyEye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recognition of CPR quality through video transmission
Recognition of CPR quality (3 conditions are randomized in each CPR, i.e. Frequency, Compression Depth, Compression Point) in Video-assisted CPR
Measured: 1 minute of CPR
Secondary outcomes (2)
Time to first chest compression
Time measured from the beginning of the emergency call to the first chest compression
Measured: Study duration (approx. 1 minute)
Precision of Geolocalisation
Precision of Geolocalisation, i.e. difference between verbally localized and automatically localized (aGPS) respondes to emergency call. Difference in runtimes of dispatched ambulances will be calculated
Measured: Study duration (approx. 1 minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start25 Aug 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test of EmergencyEye functionality in real environment, comparison with conventional emergency call.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Wolfgang A. Wetsch, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654846
- Sponsor's protocol ID
- EmergencyEye-POC
- Status last verified
- Oct 2018
- First submitted
- 25 Aug 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept
- ClinicalTrials.gov ID
- NCT03654846
- Acronym / sponsor ID
- EmergencyEye-POC
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 25 Aug 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 31 Aug 2018 (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.
Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service.
In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable.
This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.
Detailed description
Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service.
In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable, and automated localisation of the caller.
This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Test of EmergencyEye functionality in real environment, comparison with conventional emergency call.
| Arm | Type | Receives |
|---|---|---|
| Conventional emergency call | No intervention | –Emergency call with conventinal cell phone: * verbal description of location * telephone-assisted CPR |
| EmergencyEye emergency call | Experimental | Device: EmergencyEyeEmergency call with EmergencyEye App on cell phone: * automated geolocalisation * video-assisted CPR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (4 listed)
- cardiovascular diseases
- pulmonary diseases
- pregnancy
- all other conditions that make CPR impossible
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 |
|---|---|---|
| EmergencyEyeEmergencyEye Smartphone App | Device | EmergencyEye emergency call |
Primary outcome
Recognition of CPR quality through video transmission
Time frame: 1 minute of CPR
Recognition of CPR quality (3 conditions are randomized in each CPR, i.e. Frequency, Compression Depth, Compression Point) in Video-assisted CPR
2 secondary outcomes
Time to first chest compression
Time frame: Study duration (approx. 1 minute)
Precision of Geolocalisation
Time frame: Study duration (approx. 1 minute)
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 4 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmergencyEye in people with Cardiac Arrest, run by University of Cologne 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 1 inclusion and 4 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 4 Oct 2018. 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?
Recognition of CPR quality through video transmission (time frame: 1 minute of CPR). 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 4 Oct 2018.