Cardiopulmonary ResuscitationNCT02703103
Chest Compression During Resuscitation
A study testing Manual chest compressions and ARM chest compressions in people with Cardiopulmonary Resuscitation, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of the study was to evaluate the new mechanical chest compression machine LifeLine ARM in healthcare professionals in simulated model of cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- Manual chest compressions and ARM chest compressions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Feb 2016to Apr 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
Who cannot join
- not meet the above criteria
- wrist or low back diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Łukasz Szarpak
Warsaw, 00-832
Łukasz Szarpak, 500186225, lukasz.szarpak@gmail.com
About this study
Official title: Use of a New Mechanical Chest Compression Machine LifeLine ARM for Cardiopulmonary Resuscitation by Paramedics: a Randomized, Crossover, Manikin Trial
The aim of the study was to evaluate the new mechanical chest compression machine LifeLine ARM in healthcare professionals in simulated model of cardiac arrest.
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- Manual chest compressions, ARM chest compressions
- Keywords
- cardiopulmonary resuscitation, chest compression, adult, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual chest compressionsOther
2 min of Chest compressions without mechanical chest compression system
ARM chest compressionsDevice
2 min of Chest compressions with mechanical chest compression system LifeLine ARM
| Study group | Role | What they receive |
|---|---|---|
| Standard cardiopulmonary resuscitation | Experimental | standard CPR (30:2) according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation. Receives: Other: Manual chest compressions; Device: ARM chest compressions |
| asynchronous cardiopulmonary resuscitation | Experimental | asynchronuos CPR according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation. Receives: Other: Manual chest compressions; Device: ARM chest compressions |
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 (9)
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
hands-off time
defined as the sum of all periods during which no hand was placed on the chest minus time used for ventilation.
Measured: 1 day
tidal volume
volume of air delivered in a single rescue breath in milliliters
Measured: 1 day
ventilation rate
respiratory rate per minute
Measured: 1 day
minute-volume
minute volume ventilation
Measured: 1 day
number of gastric inflations
number of gastric inflations
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 posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
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
- NCT02703103
- Sponsor's protocol ID
- 02.008.1MR
- Status last verified
- Apr 2016
- First submitted
- 16 Feb 2016
- Last updated
- 6 Apr 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 26612703Kurowski A, Czyzewski L, Bogdanski L, Zasko P, Karczewska K, Szarpak L. Quality of chest compression with CardioPump CPR compared to single rescuer standard BLS. Am J Emerg Med. 2015 Jan;33(1):114-5. doi: 10.1016/j.ajem.2014.10.027. Epub 2014 Oct 20. No abstract available.
PubMed 25455057
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a New Mechanical Chest Compression Machine LifeLine ARM for Cardiopulmonary Resuscitation by Paramedics: a Randomized, Crossover, Manikin Trial
- ClinicalTrials.gov ID
- NCT02703103
- Acronym / sponsor ID
- 02.008.1MR
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- cardiopulmonary resuscitation, chest compression, adult, simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 9 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 aim of the study was to evaluate the new mechanical chest compression machine LifeLine ARM in healthcare professionals in simulated model of cardiac arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cardiopulmonary resuscitation | Experimental | Other: Manual chest compressions, Device: ARM chest compressionsstandard CPR (30:2) according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation. |
| asynchronous cardiopulmonary resuscitation | Experimental | Other: Manual chest compressions, Device: ARM chest compressionsasynchronuos CPR according to European Resuscitation Council 2015 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 (4 listed)
- give voluntary consent to participate in the study
- maximum 1 year of work experience in medicine
- minimum 10 clinical resuscitations
- paramedics
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 |
|---|---|---|
| Manual chest compressions2 min of Chest compressions without mechanical chest compression system | Other | Standard cardiopulmonary resuscitation, asynchronous cardiopulmonary resuscitation |
| ARM chest compressions2 min of Chest compressions with mechanical chest compression system LifeLine ARM | Device | Standard cardiopulmonary resuscitation, asynchronous cardiopulmonary resuscitation |
Primary outcome
chest compressions effectiveness
Time frame: 1 day
the percentage of correct chest compressions relative to the total number of chest compressions
9 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
hands-off time
Time frame: 1 day
tidal volume
Time frame: 1 day
ventilation rate
Time frame: 1 day
minute-volume
Time frame: 1 day
number of gastric inflations
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 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.
- Background: PubMed 25455057Kurowski A, Czyzewski L, Bogdanski L, Zasko P, Karczewska K, Szarpak L. Quality of chest compression with CardioPump CPR compared to single rescuer standard BLS. Am J Emerg Med. 2015 Jan;33(1):114-5. doi: 10.1016/j.ajem.2014.10.027. Epub 2014 Oct 20. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiopulmonary Resuscitation
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual chest compressions and ARM chest compressions in people with Cardiopulmonary Resuscitation, 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: status not confirmed, as of the sponsor's last update on 6 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Szarpak, PhD (500186225, lukasz.szarpak@gmail.com), or a site near the patient. 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 NCT02703103, which also lists 2 linked publications.
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 6 Apr 2016.