Chest CompressionSRPRNCT02694900
Single-rescuer Pediatric Resuscitation
A study testing Manually chest compressions, Cardiopump and LifeLine ARM in people with Chest Compression, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The objective of this pilot study was to compare the manual chest compressions (CC) versus CC feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric cardiopulmonary resuscitation Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Compression
- What is being tested?
- Manually chest compressions, Cardiopump and LifeLine ARM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to Mar 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- minimum 10 clinical resuscitations
- paramedics, nurses, physicians
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: Comparison of Three Different Chest Compressions Methods During Pediatric Cardiopulmonary Resuscitation: A Pilot, Randomized Crossover Manikin Trial
The objective of this pilot study was to compare the manual chest compressions (CC) versus CC feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric cardiopulmonary resuscitation
- Conditions
- Chest Compression
- Being tested
- Manually chest compressions, Cardiopump, LifeLine ARM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manually chest compressionsOther
Chest compressions performed manually without any device
CardiopumpDevice
Chest compressions performed with Cardiopump
LifeLine ARMDevice
Chest compressions performed using mechanical chest compressions system LifeLine ARM
| Study group | Role | What they receive |
|---|---|---|
| Resuscitation on the flor | Experimental | 2 min asynchronous cardiopulmonary resuscitation. The patient lies on the floor Receives: Other: Manually chest compressions; Device: Cardiopump; Device: LifeLine ARM |
| Resuscitation on the stretcher | Experimental | 2 min asynchronous cardiopulmonary resuscitation. The patient lies on a stretcher Receives: Other: Manually chest compressions; Device: Cardiopump; Device: LifeLine ARM |
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 (5)
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 compressions
correct chest compressions rate according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation
Measured: 1 day
Ease-of-use
To access subjective opinion about the difficulty of each chest compression method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
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 posted1 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 2016
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 Chest CompressionStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Szarpak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694900
- Sponsor's protocol ID
- 02.009.1MR
- Acronym
- SRPR
- Status last verified
- Mar 2016
- First submitted
- 16 Feb 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Truszewski Z, Szarpak L, Kurowski A, Evrin T, Zasko P, Bogdanski L, Czyzewski L. Randomized trial of the chest compressions effectiveness comparing 3 feedback CPR devices and standard basic life support by nurses. Am J Emerg Med. 2016 Mar;34(3):381-5. doi: 10.1016/j.ajem.2015.11.003. Epub 2015 Nov 4.
PubMed 26612703
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Chest Compressions Methods During Pediatric Cardiopulmonary Resuscitation: A Pilot, Randomized Crossover Manikin Trial
- ClinicalTrials.gov ID
- NCT02694900
- Acronym / sponsor ID
- SRPR / 02.009.1MR
- Conditions
- Chest Compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Mar 2016 (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 objective of this pilot study was to compare the manual chest compressions (CC) versus CC feedback device TrueCPR vs mechanical CC device LifeLine ARM during simulated pediatric cardiopulmonary resuscitation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resuscitation on the flor | Experimental | Other: Manually chest compressions, Device: Cardiopump, Device: LifeLine ARM2 min asynchronous cardiopulmonary resuscitation. The patient lies on the floor |
| Resuscitation on the stretcher | Experimental | Other: Manually chest compressions, Device: Cardiopump, Device: LifeLine ARM2 min asynchronous cardiopulmonary resuscitation. The patient lies on a stretcher |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- minimum 10 clinical resuscitations
- paramedics, nurses, physicians
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 |
|---|---|---|
| Manually chest compressionsChest compressions performed manually without any device | Other | Resuscitation on the flor, Resuscitation on the stretcher |
| CardiopumpChest compressions performed with Cardiopump | Device | Resuscitation on the flor, Resuscitation on the stretcher |
| LifeLine ARMChest compressions performed using mechanical chest compressions system LifeLine ARM | Device | Resuscitation on the flor, Resuscitation on the stretcher |
Primary outcome
chest compressions effectiveness
Time frame: 1 day
the percentage of correct chest compressions relative to the total number of chest compressions
5 secondary outcomes
Depth
Time frame: 1 day
Pressure point
Time frame: 1 day
Complete pressure release
Time frame: 1 day
Rate of chest compressions
Time frame: 1 day
Ease-of-use
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 15 Mar 2016.
- Background: PubMed 26612703Truszewski Z, Szarpak L, Kurowski A, Evrin T, Zasko P, Bogdanski L, Czyzewski L. Randomized trial of the chest compressions effectiveness comparing 3 feedback CPR devices and standard basic life support by nurses. Am J Emerg Med. 2016 Mar;34(3):381-5. doi: 10.1016/j.ajem.2015.11.003. Epub 2015 Nov 4.
- Individual participant dataSharing planned: Undecided
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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 Manually chest compressions, Cardiopump and LifeLine ARM in people with Chest Compression, run by Medical University of Warsaw 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 4 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 15 Mar 2016. 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?
On the ClinicalTrials.gov record for NCT02694900, 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 15 Mar 2016.