Cardiac ArrestfrequenzNCT02000505
Comparison of the Quality of CPR by Lay Rescuers With and Without Feedback Devices
A study testing PocketCPR, Metronome and 110bpm Song in people with Cardiac Arrest, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
Comparison of various methods to improve the quality of CPR Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- PocketCPR, Metronome and 110bpm Song
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Feb 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- lay rescuers
- >18 years
- <60 years
Who cannot join
- professional rescuers
- pregnancy
Trial locations and contacts
1 site in 1 country.
Stefan Braunecker, MD contact
Germany1 site, 1 recruiting
- Recruiting
Uniklinik Köln
Cologne, 50937
Stefan Braunecker, MD, 0221-478-97729, stefan.braunecker@uk-koeln.de
Stefan Braunecker, MD
About this study
Official title: Comparison of the Quality of CPR by Lay Rescuers With and Without Telephone Instructions by a Simulated Rescue Coordination Center
Comparison of various methods to improve the quality of CPR
Read the detailed description
Even for paramedics and emergency physicians, the resuscitation of patients with cardiac arrest remains a challenge. Previous studies have shown that the cardiac output varies widely even among professional helpers. This is especially due to some very different mean frequencies of cardiac compression wich vary from 60 to 160/min for paramedics. Aim of this study is to investigate whether the use of feedback-devices during cardiac-pulmonary resuscitation (CPR) can lead to an improvement of the cardiac output and may improve survival.
For this, we examine the impact of different feedback-methods on the frequence-variety on manikin by lay rescuers. Overall, we compare three different devices for feedback during CPR. The subjects for this study are lay rescuers who perform a 5 minute chest-compression-only CPR.
- Conditions
- Cardiac Arrest
- Being tested
- PocketCPR, Metronome, 110bpm Song
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PocketCPRDevice
5 minutes chest-compression-only CPR, using Zoll PocketCPR
MetronomeDevice
5 minutes chest-compression-only CPR, using a metronome
110bpm SongDevice
5 minutes chest-compression-only CPR, using a song with 110bpm for support
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 5 minutes chest-compression-only CPR, without any support |
| PocketCPR | Experimental | 5 minutes chest-compression-only CPR, with support Receives: Device: PocketCPR |
| Metronome | Experimental | 5 minutes chest-compression-only CPR, with support Receives: Device: Metronome |
| 110bpm Song | Experimental | 5 minutes chest-compression-only CPR, with support Receives: Device: 110bpm Song |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average achieved cardiac output
The main goal of the study is the average achieved cardiac output. Data acquisition is carried out on a resuscitation-manikin which can measure compression-rate (CR) and compression-depth (CD). The data are recorded by a computer during the CPR. To calculate the cardiac output, we multiply the average CR [1/min] with the average CD [mm] during the 5 min manikin-resuscitation. The thus obtained average cardiac-output (CO = CR x CD), measured in [mm/min], will be compared in each group.
Measured: after 5 minutes
Secondary outcomes (1)
Constancy of the quality of chest-compressions
Second objective of the study is the variation of the compression-rate and the compression-depth during the resuscitation. We compare the average compression-rate and compression-depth of the first 30 compressions and the last 30 compression of every participant. As a result, the average standard deviation in each group will be calculated. Afterward, the groups will be compared using the mean deviation of every group. The mean deviation will be measured in +/-[mm] for compression-depth and +/-[1/min] for compression rate.
Measured: after 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Stefan Braunecker, University Hospital of Cologne
- Investigators
- Stefan Braunecker, MD, Principal investigator, University Hospital of CologneJochen Hinkelbein, MD, Study director, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000505
- Sponsor's protocol ID
- 10-333
- Acronym
- frequenz
- Status last verified
- May 2015
- First submitted
- 17 Nov 2013
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Quality of CPR by Lay Rescuers With and Without Telephone Instructions by a Simulated Rescue Coordination Center
- ClinicalTrials.gov ID
- NCT02000505
- Acronym / sponsor ID
- frequenz / 10-333
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 4 Dec 2013 (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.
Comparison of various methods to improve the quality of CPR
Detailed description
Even for paramedics and emergency physicians, the resuscitation of patients with cardiac arrest remains a challenge. Previous studies have shown that the cardiac output varies widely even among professional helpers. This is especially due to some very different mean frequencies of cardiac compression wich vary from 60 to 160/min for paramedics. Aim of this study is to investigate whether the use of feedback-devices during cardiac-pulmonary resuscitation (CPR) can lead to an improvement of the cardiac output and may improve survival.
For this, we examine the impact of different feedback-methods on the frequence-variety on manikin by lay rescuers. Overall, we compare three different devices for feedback during CPR. The subjects for this study are lay rescuers who perform a 5 minute chest-compression-only CPR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –5 minutes chest-compression-only CPR, without any support |
| PocketCPR | Experimental | Device: PocketCPR5 minutes chest-compression-only CPR, with support |
| Metronome | Experimental | Device: Metronome5 minutes chest-compression-only CPR, with support |
| 110bpm Song | Experimental | Device: 110bpm Song5 minutes chest-compression-only CPR, with support |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- lay rescuers
- >18 years
- <60 years
Key exclusion criteria (2 listed)
- professional rescuers
- pregnancy
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 |
|---|---|---|
| PocketCPR5 minutes chest-compression-only CPR, using Zoll PocketCPR | Device | PocketCPR |
| Metronome5 minutes chest-compression-only CPR, using a metronome | Device | Metronome |
| 110bpm Song5 minutes chest-compression-only CPR, using a song with 110bpm for support | Device | 110bpm Song |
Primary outcome
The average achieved cardiac output
Time frame: after 5 minutes
The main goal of the study is the average achieved cardiac output. Data acquisition is carried out on a resuscitation-manikin which can measure compression-rate (CR) and compression-depth (CD). The data are recorded by a computer during the CPR. To calculate the cardiac output, we multiply the average CR [1/min] with the average CD [mm] during the 5 min manikin-resuscitation. The thus obtained average cardiac-output (CO = CR x CD), measured in [mm/min], will be compared in each group.
1 secondary outcome
Constancy of the quality of chest-compressions
Time frame: after 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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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.
Stefan Braunecker, MD contact
Stefan Braunecker, MD principal investigator
University Hospital of Cologne
Jochen Hinkelbein, MD study director
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PocketCPR, Metronome and 110bpm Song in people with Cardiac Arrest, run by University Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Braunecker, MD (stefan.braunecker@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average achieved cardiac output (time frame: after 5 minutes). 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 5 May 2015.