Cardiac ArrestNCT03527771
Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study
A study testing Video-assisted CPR and telephone-assisted CPR 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?
- Video-assisted CPR and telephone-assisted CPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 8 Aug 2018to 28 Aug 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 volunteer
Who cannot join
- healthcare providers (medical practitioners, nurses, paramedics etc.)
- pregnant women
- people with cardio-pulmonary and musculoskeletal diseases or any other impairment that would risk harm for the volunteer while performing CPR for 8 minutes
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Intensive 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 trail yet and no data exists that shows if V-CPR in comparison to T-CPR and non-instructed CPR leads to a better bystander CPR-performance.
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.
This technology hasn't been tested in a randomized controlled trail yet and no data exists that shows if V-CPR in comparison to T-CPR and non-instructed CPR leads to a better bystander CPR-performance.
- Conditions
- Cardiac Arrest
- Being tested
- Video-assisted CPR, telephone-assisted CPR
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted CPRDevice
Emergency call using a Software capable of video Transmission for Video assistance in CPR
telephone-assisted CPRDrug
Emergency call with telephone assistance in CPR
| Study group | Role | What they receive |
|---|---|---|
| unassisted CPR | No intervention | unassisted CPR |
| T-CPR | Active comparator | telephone assisted CPR according to ERC Guidelines 2015 Receives: Drug: telephone-assisted CPR |
| V-CPR | Experimental | video-assisted CPR according to ERC Guidelines 2015 Receives: Device: Video-assisted CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR Compression Frequency
CPR Compression Frequency
Measured: 8 minutes
Secondary outcomes (4)
Compression Depth
Compression Depth
Measured: 8 minutes
Cumulative No-Flow Time
Cumulative No-Flow Time
Measured: Up to 8 minutes
Time to diagnosis
Time to diagnosis
Measured: Up to 8 minutes
Time to beginning of chest compressions
Time to beginning of chest compressions
Measured: Up to 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start8 Aug 2018
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT03527771
- Sponsor's protocol ID
- EmergencyEye-POP
- Status last verified
- Aug 2018
- First submitted
- 3 May 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ecker H, Lindacher F, Adams N, Hamacher S, Wingen S, Schier R, Bottiger BW, Wetsch WA. Video-assisted cardiopulmonary resuscitation via smartphone improves quality of resuscitation: A randomised controlled simulation trial. Eur J Anaesthesiol. 2020 Apr;37(4):294-302. doi: 10.1097/EJA.0000000000001177.
PubMed 32073408
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 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
- ClinicalTrials.gov ID
- NCT03527771
- Acronym / sponsor ID
- EmergencyEye-POP
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 17 May 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 trail yet and no data exists that shows if V-CPR in comparison to T-CPR and non-instructed CPR leads to a better bystander CPR-performance.
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.
This technology hasn't been tested in a randomized controlled trail yet and no data exists that shows if V-CPR in comparison to T-CPR and non-instructed CPR leads to a better bystander CPR-performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| unassisted CPR | No intervention | –unassisted CPR |
| T-CPR | Active comparator | Drug: telephone-assisted CPRtelephone assisted CPR according to ERC Guidelines 2015 |
| V-CPR | Experimental | Device: Video-assisted CPRvideo-assisted CPR according to ERC Guidelines 2015 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteer
Key exclusion criteria (3 listed)
- healthcare providers (medical practitioners, nurses, paramedics etc.)
- pregnant women
- people with cardio-pulmonary and musculoskeletal diseases or any other impairment that would risk harm for the volunteer while performing CPR for 8 minutes
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 |
|---|---|---|
| Video-assisted CPREmergency call using a Software capable of video Transmission for Video assistance in CPR | Device | V-CPR |
| telephone-assisted CPREmergency call with telephone assistance in CPR | Drug | T-CPR |
Primary outcome
CPR Compression Frequency
Time frame: 8 minutes
CPR Compression Frequency
4 secondary outcomes
Compression Depth
Time frame: 8 minutes
Cumulative No-Flow Time
Time frame: Up to 8 minutes
Time to diagnosis
Time frame: Up to 8 minutes
Time to beginning of chest compressions
Time frame: Up to 8 minutes
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 31 Aug 2018.
- Derived from this study: PubMed 32073408Ecker H, Lindacher F, Adams N, Hamacher S, Wingen S, Schier R, Bottiger BW, Wetsch WA. Video-assisted cardiopulmonary resuscitation via smartphone improves quality of resuscitation: A randomised controlled simulation trial. Eur J Anaesthesiol. 2020 Apr;37(4):294-302. doi: 10.1097/EJA.0000000000001177.
- 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.
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 Video-assisted CPR and telephone-assisted CPR 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 3 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 31 Aug 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?
CPR Compression Frequency (time frame: 8 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527771, which also lists 1 linked publication.
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 31 Aug 2018.