Cardiac ArrestPRFDNCT02281903
Pediatric Resuscitation With Feedback CPR Devices
A study testing The TrueCPR feedback device and Standard BLS in people with Cardiac Arrest, run by International Institute of Rescue Research and Education at 1 site in Poland.
Trial summary
The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation. 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?
- The TrueCPR feedback device and Standard BLS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2014to Nov 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
- medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)
Who cannot join
- not meet the above criteria
- wrist or low back diseases
Trial locations and contacts
1 site in 1 country.
Poland1 site
International Institute of Rescue Research and Education
Warsaw, Masovia, 03-122
About this study
Official title: Is Chest Compressions Using the TrueCPRTM Feedback Device More Effective Than Manual Compressions During Pediatric Resuscitation? A Manikin Study
The aim of this study was to compare the TrueCPR feedback device (with metronome) to standard basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation. Therefore, our hypothesis was that there would be no difference between both CPR methods in terms of chest compression quality parameters.
Read the detailed description
Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.
- Conditions
- Cardiac Arrest
- Being tested
- The TrueCPR feedback device, Standard BLS
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The TrueCPR feedback deviceDevice
feedback devices
Standard BLSDevice
Standard basic life support = chest compressions without any feedback device (manual resuscitation)
| Study group | Role | What they receive |
|---|---|---|
| Chest compression of manikins chest | Experimental | Compression of pediatric manikins chest according European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation. Receives: Device: The TrueCPR feedback device; Device: Standard BLS |
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 posted4 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 2014
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
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
- NCT02281903
- Sponsor's protocol ID
- CPR/2014/05
- Acronym
- PRFD
- Status last verified
- Nov 2014
- First submitted
- 30 Oct 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
- Is Chest Compressions Using the TrueCPRTM Feedback Device More Effective Than Manual Compressions During Pediatric Resuscitation? A Manikin Study
- ClinicalTrials.gov ID
- NCT02281903
- Acronym / sponsor ID
- PRFD / CPR/2014/05
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- International Institute of Rescue Research and EducationUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 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 this study was to compare the TrueCPR feedback device (with metronome) to standard basic life support (BLS) in terms of the quality of single rescuer pediatric resuscitation. Therefore, our hypothesis was that there would be no difference between both CPR methods in terms of chest compression quality parameters.
Detailed description
Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest compression of manikins chest | Experimental | Device: The TrueCPR feedback device, Device: Standard BLSCompression of pediatric manikins chest according European Resuscitation Council 2010 guidelines for cardiopulmonary resuscitation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- give voluntary consent to participate in the study
- medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)
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 |
|---|---|---|
| The TrueCPR feedback devicefeedback devices | Device | Chest compression of manikins chest |
| Standard BLSStandard basic life support = chest compressions without any feedback device (manual resuscitation) | Device | Chest compression of manikins chest |
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
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 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 The TrueCPR feedback device and Standard BLS 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 2 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: finished, 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?
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?
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.