ResuscitationNCT04039997
How to Learn Cardiopulmonary Resuscitation
A study testing CPRMeter and Manual chest compression in people with Resuscitation and Chest Compression, run by Lazarski University at 1 site in Poland.
Trial summary
the aim of the study is to evaluate two methods of teaching cardiopulmonary resuscitation in the context of chest compression quality. We will evaluate the usefulness of the application cpr feedback device (CPRMeter) for quality of chest compression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resuscitation, Chest Compression, Quality
- What is being tested?
- CPRMeter and Manual chest compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jul 2019to 3 Aug 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give voluntary consent to participate in the study
- no medical experience
Who cannot join
- not meet the above criteria
- wrist or low back diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Chest Compression Techniques Among Laypersons. A Prospective, Randomized Simulation Study
the aim of the study is to evaluate two methods of teaching cardiopulmonary resuscitation in the context of chest compression quality. We will evaluate the usefulness of the application cpr feedback device (CPRMeter) for quality of chest compression.
- Conditions
- Resuscitation, Chest Compression, Quality
- Being tested
- CPRMeter, Manual chest compression
- Keywords
- cardiopulmonary resuscitation, medical simulation, basic life support, chest compression, feedback device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPRMeterDevice
teaching resuscitation with application of cpr feedback device
Manual chest compressionOther
Manual chest compression
| Study group | Role | What they receive |
|---|---|---|
| Chest compression without cpr feedback device | Experimental | teaching resuscitation without application of cpr feedback device Receives: Other: Manual chest compression |
| Chest compression with cpr feedback device | Experimental | teaching resuscitation with application of CPRMeter - cpr feedback device Receives: Device: CPRMeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest compressions effectiveness
the percentage of correct chest compressions relative to the total number of chest compressions
Measured: 1 day
Secondary outcomes (4)
depth
correct depth according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation
Measured: 1 day
pressure point
correct pressure point according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation
Measured: 1 day
Complete pressure release
Complete pressure release measure by manikin software
Measured: 1 day
Rate of chest compression
correct chest compressions rate according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start20 Jul 2019
- Primary completion3 Aug 2019
- Study completion3 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResuscitationStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, The Cleveland Clinic
- Responsible party
- Principal investigator, Łukasz Szarpak, Lazarski University
- Investigators
- Lukasz Szarpak, Study chair, Lazarski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039997
- Sponsor's protocol ID
- CPR_NET
- Status last verified
- Apr 2020
- First submitted
- 29 Jul 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after finish study, we will share data on https://repod.pon.edu.pl/pl/
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Chest Compression Techniques Among Laypersons. A Prospective, Randomized Simulation Study
- ClinicalTrials.gov ID
- NCT04039997
- Acronym / sponsor ID
- CPR_NET
- Conditions
- Resuscitation, Chest Compression, Quality
- Keywords
- cardiopulmonary resuscitation, medical simulation, basic life support, chest compression, feedback device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, The Cleveland Clinic
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 3 Aug 2019 (actual)
- Study completion
- 3 Aug 2019 (actual)
- First posted
- 31 Jul 2019 (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.
the aim of the study is to evaluate two methods of teaching cardiopulmonary resuscitation in the context of chest compression quality. We will evaluate the usefulness of the application cpr feedback device (CPRMeter) for quality of chest compression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest compression without cpr feedback device | Experimental | Other: Manual chest compressionteaching resuscitation without application of cpr feedback device |
| Chest compression with cpr feedback device | Experimental | Device: CPRMeterteaching resuscitation with application of CPRMeter - cpr feedback device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- give voluntary consent to participate in the study
- no medical experience
Key exclusion criteria (3 listed)
- not meet the above criteria
- wrist or low back diseases
- 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 |
|---|---|---|
| CPRMeterteaching resuscitation with application of cpr feedback device | Device | Chest compression with cpr feedback device |
| Manual chest compressionManual chest compression | Other | Chest compression without cpr feedback device |
Primary outcome
chest compressions effectiveness
Time frame: 1 day
the percentage of correct chest compressions relative to the total number of chest compressions
4 secondary outcomes
depth
Time frame: 1 day
pressure point
Time frame: 1 day
Complete pressure release
Time frame: 1 day
Rate of chest compression
Time frame: 1 day
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 28 Apr 2020.
- Individual participant dataSharing planned: Undecided. after finish study, we will share data on https://repod.pon.edu.pl/pl/
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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.
Lukasz Szarpak study chair
Lazarski University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPRMeter and Manual chest compression in people with Resuscitation and Chest Compression, run by Lazarski University at 1 site in Poland.
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 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 28 Apr 2020. 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 Poland. 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?
chest compressions effectiveness (time frame: 1 day). 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 28 Apr 2020.