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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Italy

Switzerland4 sites
  • FormaMed Sàrl

    Cortaillod, 2016

  • Emergency Training Center

    Cugy, 1053

  • ES ASUR

    Le Mont-sur-Lausanne, 1052

  • FCTSA

    Lugano, 6932

Other trials in Switzerland

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 groups in NCT02632500
Study groupRoleWhat they receive
30 compressions and 2 seconds of pauseExperimentalAfter 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 pausesExperimentalAfter 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 pauseExperimentalAfter 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-onlyExperimentalAfter 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  1. First posted16 Dec 2015 (estimated)
  2. Study startApr 2016
  3. Primary completion28 Apr 2019
  4. Study completion28 Apr 2019

Resources

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)
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 32976224
  • Baldi 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

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.

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