Cardiac ArrestNCT02293200
CPR Feedback Devices
A study testing Standard BLS and TrueCPR in people with Cardiac Arrest, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The aim of the study was to compare two methods of training in CPR, standard basic life support and CPR using CPR feedback device. 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?
- Standard BLS and TrueCPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2014to Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Give voluntary consent to participate in the study
Who cannot join
- Not meet the above criteria
- Wrist or low back diseases
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
International Institute of Rescue Research and Education
Warsaw, Masovia, 03-122
Lukasz Szarpak, +48500186225, lukasz.szarpak@gmail.com
About this study
Official title: TWO METHODS OF TRAINING TO IMPROVE CHEST COMPRESSION EFFECITVENESS BY MEDICAL STUDENTS AND BYSTANDERS: A Randomized Trial
The aim of the study was to compare two methods of training in CPR, standard basic life support and CPR using CPR feedback device.
- Conditions
- Cardiac Arrest
- Being tested
- Standard BLS, TrueCPR
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard BLSDevice
basic life support without any feedback device
TrueCPRDevice
CPR with feedback device
| Study group | Role | What they receive |
|---|---|---|
| Traditional learning | Experimental | chest compression group learning without CPR feedback device. After a month of quality control of chest compressions is made also without the device. Receives: Device: Standard BLS |
| Experimental learning | Experimental | Training is done using TrueCPR feedback device. After a month of quality control of chest compressions is made without the device. To do this will be indicated on the impact of the use of feedback devices for improving the effectiveness of training in CPR. Receives: Device: Standard BLS; Device: TrueCPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions
effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions
Measured: 1 month
Secondary outcomes (4)
effective compressions ratio effective compressions [%] multiplied by flow time [%]
effective compressions ratio was defined as effective compressions [%] multiplied by flow time [%]
Measured: 1 month
Flow time sum of all periods during which chest compressions were performed.
flow time was defined as the sum of all periods during which chest compressions were performed.
Measured: 1 month
absolute hands-off time sum of all periods without chest compressions or ventilation
absolute hands-off time (HOT) was defined as the sum of all periods without chest compressions or ventilation
Measured: 1 month
Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Institute of Rescue Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Szarpak, National Institute of Cardiology, Warsaw, Poland
- Investigators
- Lukasz Szarpak, Principal investigator, Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293200
- Sponsor's protocol ID
- CPR/2014/03
- Status last verified
- Nov 2014
- First submitted
- 13 Nov 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TWO METHODS OF TRAINING TO IMPROVE CHEST COMPRESSION EFFECITVENESS BY MEDICAL STUDENTS AND BYSTANDERS: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02293200
- Acronym / sponsor ID
- CPR/2014/03
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Nov 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 aim of the study was to compare two methods of training in CPR, standard basic life support and CPR using CPR feedback device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional learning | Experimental | Device: Standard BLSchest compression group learning without CPR feedback device. After a month of quality control of chest compressions is made also without the device. |
| Experimental learning | Experimental | Device: Standard BLS, Device: TrueCPRTraining is done using TrueCPR feedback device. After a month of quality control of chest compressions is made without the device. To do this will be indicated on the impact of the use of feedback devices for improving the effectiveness of training in CPR. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Give voluntary consent to participate in the study
Key exclusion criteria (2 listed)
- Not meet the above criteria
- Wrist or low back diseases
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 |
|---|---|---|
| Standard BLSbasic life support without any feedback device | Device | Experimental learning, Traditional learning |
| TrueCPRCPR with feedback device | Device | Experimental learning |
Primary outcome
Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions
Time frame: 1 month
effective compressions was defined as compression with correct depth (40-50mm), correct hand position and complete decompressions
4 secondary outcomes
effective compressions ratio effective compressions [%] multiplied by flow time [%]
Time frame: 1 month
Flow time sum of all periods during which chest compressions were performed.
Time frame: 1 month
absolute hands-off time sum of all periods without chest compressions or ventilation
Time frame: 1 month
Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Lukasz Szarpak principal investigator
Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard BLS and TrueCPR in people with Cardiac Arrest, run by International Institute of Rescue Research and Education 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 1 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 18 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Kurowski (+48500186225, andrzejkurowski987@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions (time frame: 1 month). 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 18 Nov 2014.