Quality of Cardio-pulmonary ResuscitationMANI-CPRNCT02632500
Manikin Study on Different Protocols of CPR (MANI-CPR)
A study testing Quality of chest compressions in people with Quality of Cardio-pulmonary Resuscitation, run by Pavia nel Cuore at 8 sites in 2 countries.
Trial summary
The aim of the study is to verify whether the inclusion of breaks of different frequency and duration during the hands-only cardio-pulmonary resuscitation (CPR) could increase chest compressions quality during an 8-minutes scenario. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Cardio-pulmonary Resuscitation
- What is being tested?
- Quality of chest compressions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Apr 2016to 28 Apr 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lay people over 18 years old
Who cannot join
- Lay people over 80 years old
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Italy4 sites
Policlinico P. Giaccone
Palermo, PA, 90127
Pavia nel Cuore
Pavia, PV, 27100
Centro Studi e Formazione Gymnasium
Pordenone, PN, 33170
Robbio nel Cuore
Robbio, Pavia, 27038
Switzerland4 sites
FormaMed Sàrl
Cortaillod, 2016
Emergency Training Center
Cugy, 1053
ES ASUR
Le Mont-sur-Lausanne, 1052
FCTSA
Lugano, 6932
About this study
Official title: Multicenter internAtional raNdomized Controlled manIkin Study on Different Protocols of CPR (MANI-CPR)
The aim of the study is to verify whether the inclusion of breaks of different frequency and duration during the hands-only cardio-pulmonary resuscitation (CPR) could increase chest compressions quality during an 8-minutes scenario.
Read the detailed description
Background:
The focus on the hands-only CPR has grown a lot in the last years. The reasons for this are that it's more accepted by lay rescuers, it's easier to remember and to perform, and, above all, it has been demonstrated that it has the same efficacy than standard CPR at least in the first minutes after an out-of-hospital cardiac arrest (OHCA), which are the minutes in which it is more probably that a lay rescuer can intervene. For these reasons ILCOR 2010 and also 2015 guidelines recommended this technique for untrained bystanders or for bystanders who are unwilling to give rescue breaths. ILCOR 2010 and 2015 guidelines have also pointed out that it's not sufficient to perform only a CPR immediately after an OHCA. In fact they have stressed that this CPR must be an high-quality CPR, that is a CPR with compressions of adequate rate (between 100 and 120 per minute) and adequate depth (between 5 and 6 cm), with complete chest recoil between compressions and minimizing interruptions between compressions. This because it has been shown that an high-quality CPR can improve the survival after an OHCA. It has also been demonstrated that the quality of hands-only CPR decades after 1 minute, and considering that the mean time intervention of Emergency Medical System (EMS) on a cardiac arrest scenario in Europe is about 8 minute, it's easy to comprehend that it is very difficult to perform an high-quality CPR with the hands-only technique. It has also been shown that a 10-seconds pause in the hands-only CPR protocol can increase its quality, but, at the moment, there is not a shared protocol to recommend to lay rescuers who are unwilling to give rescue breaths, except to perform chest compressions continuously until EMS arrival.
Purpose:
The aim of the study is to verify whether the inclusion of breaks of different frequency and duration during CPR could increase chest compressions quality during an 8-minutes scenario compared with the hands-only CPR technique.
Materials and Methods:
The study involves multiple training center in Italy and in Europe, that organise Basic Life Support with Automated External Defibrillators (BLS/AED) courses according to ILCOR 2015 guidelines, with an instructor:attendees:manikin ratio of 1:5:1, maximum 1:6:1, and with 1 minute training per participant with real-time feedback using a Laerdal QCPR or Resusci Anne Wireless Skill Reporter manikin connected with a QCPR software. At the end of each course the performance of 1-min of compression-only CPR on the QCPR/Resusci Anne Wireless Skill Reporter manikin without visual feedback for the attendee will be recorded for each participant. In order to eliminate any bias due to heterogeneity of the individual quality of CPR, will be asked to participate in the study to all those who, at the end of this test, will have done the compressions at a rate between 100 and 120 per minute with a result> = 75% in the parameters "percentage of compressions with correct depths (between 5 and 6 cm)", "percentage of correctly released compressions", "percentage of compressions with correct hand position" Those who are between 18 and 80 years old and agree to participate in signing the informed consent, will be randomized to one of four arms of the study. The arms of the study are the 4 different CPR protocols: 30 compressions and 2 seconds of pause (30c2s), 50 compressions and 5 seconds of pause (50c5s), 100 compressions and a 10 seconds of pause (100c10s) and continuous chest compressions without any pauses (hands-only).
The subjects were asked to carry out an 8-minutes performance following the protocol assigned to them on the Laerdal QCPR or Resusci Anne Wireless Skill Reporter manikin connected to the QCPR software without any type of feedback or help.
- Being tested
- Quality of chest compressions
- Keywords
- Cardio-Pulmonary Resuscitation, Cardiac Arrest, Training
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of chest compressionsOther
| Study group | Role | What they receive |
|---|---|---|
| 30 compressions and 2 seconds of pause | Experimental | After the randomization the participant will be asked to perform 8 minutes of CPR following the "30 compressions and 2 seconds of pause" protocol (30 chest compressions followed by 2 seconds of pause) on a manikin connected to the Personal Computer. Receives: Other: Quality of chest compressions |
| 50 compressions and 5 seconds of pauses | Experimental | After the randomization the participant will be asked to perform 8 minutes of CPR following the "50 compressions and 5 seconds of pause" protocol (50 chest compressions followed by 5 seconds of pause) on a manikin connected to the Personal Computer. Receives: Other: Quality of chest compressions |
| 100 compressions and 10 seconds of pause | Experimental | After the randomization the participant will be asked to perform 8 minutes of CPR following the "100 compressions and 10 seconds of pause" protocol (100 chest compressions followed by 10 seconds of pause) on a manikin connected to the Personal Computer. Receives: Other: Quality of chest compressions |
| hands-only | Experimental | After the randomization the participant will be asked to perform 8 minutes of CPR following the "hands-only" protocol (continuous chest compressions without any pauses) on a manikin connected to the Personal Computer. Receives: Other: Quality of chest compressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest compressions depth
Difference in the percentage of compressions with correct depth (50-60 mm) among the groups
Measured: The whole 8 minutes of the performance carried out by each subject.
Secondary outcomes (4)
Correctly released compressions
Differences in the percentage of correctly released compressions among the groups
Measured: The whole 8 minutes of the performance carried out by each subject.
Compressions with correct hand position
Differences in the percentage of compressions with correct hand position among the groups
Measured: The whole 8 minutes of the performance carried out by each subject.
Number of compressions per minute
Difference in the percentage of compressions with correct rythm among the groups
Measured: The whole 8 minutes of the performance carried out by each subject.
Pauses to rest
Lengths of the pauses taken to rest
Measured: The whole 8 minutes of the performance carried out by each subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startApr 2016
- Primary completion28 Apr 2019
- Study completion28 Apr 2019
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 Quality of Cardio-pulmonary 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pavia nel Cuore
- Sponsor type
- University, hospital or other
- Collaborators
- Robbio nel Cuore
- Responsible party
- Principal investigator, Enrico Baldi, Pavia nel Cuore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632500
- Sponsor's protocol ID
- ProtocolsCPR
- Acronym
- MANI-CPR
- Status last verified
- May 2019
- First submitted
- 10 Dec 2015
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Baldi E, Contri E, Burkart R, Borrelli P, Ferraro OE, Paglino M, Pugliesi M, Barbati C, Bertaia D, Tami C, Lopez D, Boldarin S, Denereaz S, Terrapon M, Cortegiani A; and the MANI-CPR investigators. A Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for Laypeople: The MANI-CPR Trial. Simul Healthc. 2021 Aug 1;16(4):239-245. doi: 10.1097/SIH.0000000000000505.
PubMed 32976224Baldi E, Contri E, Burkart R, Borrelli P, Ferraro OE, Tonani M, Cutuli A, Bertaia D, Iozzo P, Tinguely C, Lopez D, Boldarin S, Deiuri C, Denereaz S, Denereaz Y, Terrapon M, Tami C, Cereda C, Somaschini A, Cornara S, Cortegiani A. Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR). BMJ Open. 2018 Apr 19;8(4):e019723. doi: 10.1136/bmjopen-2017-019723.
PubMed 29674365
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter internAtional raNdomized Controlled manIkin Study on Different Protocols of CPR (MANI-CPR)
- ClinicalTrials.gov ID
- NCT02632500
- Acronym / sponsor ID
- MANI-CPR / ProtocolsCPR
- Keywords
- Cardio-Pulmonary Resuscitation, Cardiac Arrest, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Pavia nel CuoreUniversity, hospital or other
- Collaborators
- Robbio nel Cuore
- Study start
- Apr 2016 (actual)
- Primary completion
- 28 Apr 2019 (actual)
- Study completion
- 28 Apr 2019 (actual)
- First posted
- 16 Dec 2015 (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 is to verify whether the inclusion of breaks of different frequency and duration during the hands-only cardio-pulmonary resuscitation (CPR) could increase chest compressions quality during an 8-minutes scenario.
Detailed description
Background:
The focus on the hands-only CPR has grown a lot in the last years. The reasons for this are that it's more accepted by lay rescuers, it's easier to remember and to perform, and, above all, it has been demonstrated that it has the same efficacy than standard CPR at least in the first minutes after an out-of-hospital cardiac arrest (OHCA), which are the minutes in which it is more probably that a lay rescuer can intervene. For these reasons ILCOR 2010 and also 2015 guidelines recommended this technique for untrained bystanders or for bystanders who are unwilling to give rescue breaths. ILCOR 2010 and 2015 guidelines have also pointed out that it's not sufficient to perform only a CPR immediately after an OHCA. In fact they have stressed that this CPR must be an high-quality CPR, that is a CPR with compressions of adequate rate (between 100 and 120 per minute) and adequate depth (between 5 and 6 cm), with complete chest recoil between compressions and minimizing interruptions between compressions. This because it has been shown that an high-quality CPR can improve the survival after an OHCA. It has also been demonstrated that the quality of hands-only CPR decades after 1 minute, and considering that the mean time intervention of Emergency Medical System (EMS) on a cardiac arrest scenario in Europe is about 8 minute, it's easy to comprehend that it is very difficult to perform an high-quality CPR with the hands-only technique. It has also been shown that a 10-seconds pause in the hands-only CPR protocol can increase its quality, but, at the moment, there is not a shared protocol to recommend to lay rescuers who are unwilling to give rescue breaths, except to perform chest compressions continuously until EMS arrival.
Purpose:
The aim of the study is to verify whether the inclusion of breaks of different frequency and duration during CPR could increase chest compressions quality during an 8-minutes scenario compared with the hands-only CPR technique.
Materials and Methods:
The study involves multiple training center in Italy and in Europe, that organise Basic Life Support with Automated External Defibrillators (BLS/AED) courses according to ILCOR 2015 guidelines, with an instructor:attendees:manikin ratio of 1:5:1, maximum 1:6:1, and with 1 minute training per participant with real-time feedback using a Laerdal QCPR or Resusci Anne Wireless Skill Reporter manikin connected with a QCPR software. At the end of each course the performance of 1-min of compression-only CPR on the QCPR/Resusci Anne Wireless Skill Reporter manikin without visual feedback for the attendee will be recorded for each participant. In order to eliminate any bias due to heterogeneity of the individual quality of CPR, will be asked to participate in the study to all those who, at the end of this test, will have done the compressions at a rate between 100 and 120 per minute with a result> = 75% in the parameters "percentage of compressions with correct depths (between 5 and 6 cm)", "percentage of correctly released compressions", "percentage of compressions with correct hand position" Those who are between 18 and 80 years old and agree to participate in signing the informed consent, will be randomized to one of four arms of the study. The arms of the study are the 4 different CPR protocols: 30 compressions and 2 seconds of pause (30c2s), 50 compressions and 5 seconds of pause (50c5s), 100 compressions and a 10 seconds of pause (100c10s) and continuous chest compressions without any pauses (hands-only).
The subjects were asked to carry out an 8-minutes performance following the protocol assigned to them on the Laerdal QCPR or Resusci Anne Wireless Skill Reporter manikin connected to the QCPR software without any type of feedback or help.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 30 compressions and 2 seconds of pause | Experimental | Other: Quality of chest compressionsAfter the randomization the participant will be asked to perform 8 minutes of CPR following the "30 compressions and 2 seconds of pause" protocol (30 chest compressions followed by 2 seconds of pause) on a manikin connected to the Personal Computer. |
| 50 compressions and 5 seconds of pauses | Experimental | Other: Quality of chest compressionsAfter the randomization the participant will be asked to perform 8 minutes of CPR following the "50 compressions and 5 seconds of pause" protocol (50 chest compressions followed by 5 seconds of pause) on a manikin connected to the Personal Computer. |
| 100 compressions and 10 seconds of pause | Experimental | Other: Quality of chest compressionsAfter the randomization the participant will be asked to perform 8 minutes of CPR following the "100 compressions and 10 seconds of pause" protocol (100 chest compressions followed by 10 seconds of pause) on a manikin connected to the Personal Computer. |
| hands-only | Experimental | Other: Quality of chest compressionsAfter the randomization the participant will be asked to perform 8 minutes of CPR following the "hands-only" protocol (continuous chest compressions without any pauses) on a manikin connected to the Personal Computer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lay people over 18 years old
Key exclusion criteria (1 listed)
- Lay people over 80 years old
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 |
|---|---|---|
| Quality of chest compressions | Other | 100 compressions and 10 seconds of pause, 30 compressions and 2 seconds of pause, 50 compressions and 5 seconds of pauses, hands-only |
Primary outcome
Chest compressions depth
Time frame: The whole 8 minutes of the performance carried out by each subject.
Difference in the percentage of compressions with correct depth (50-60 mm) among the groups
4 secondary outcomes
Correctly released compressions
Time frame: The whole 8 minutes of the performance carried out by each subject.
Compressions with correct hand position
Time frame: The whole 8 minutes of the performance carried out by each subject.
Number of compressions per minute
Time frame: The whole 8 minutes of the performance carried out by each subject.
Pauses to rest
Time frame: The whole 8 minutes of the performance carried out by each subject.
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 7 May 2019.
- Derived from this study: PubMed 32976224Baldi E, Contri E, Burkart R, Borrelli P, Ferraro OE, Paglino M, Pugliesi M, Barbati C, Bertaia D, Tami C, Lopez D, Boldarin S, Denereaz S, Terrapon M, Cortegiani A; and the MANI-CPR investigators. A Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for Laypeople: The MANI-CPR Trial. Simul Healthc. 2021 Aug 1;16(4):239-245. doi: 10.1097/SIH.0000000000000505.
- Derived from this study: PubMed 29674365Baldi E, Contri E, Burkart R, Borrelli P, Ferraro OE, Tonani M, Cutuli A, Bertaia D, Iozzo P, Tinguely C, Lopez D, Boldarin S, Deiuri C, Denereaz S, Denereaz Y, Terrapon M, Tami C, Cereda C, Somaschini A, Cornara S, Cortegiani A. Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR). BMJ Open. 2018 Apr 19;8(4):e019723. doi: 10.1136/bmjopen-2017-019723.
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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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of chest compressions in people with Quality of Cardio-pulmonary Resuscitation, run by Pavia nel Cuore at 8 sites in 2 countries.
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 1 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Switzerland. 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 depth (time frame: The whole 8 minutes of the performance carried out by each subject.). 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 NCT02632500, 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 7 May 2019.