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Manikin Study on Different Protocols of CPR (MANI-CPR) (MANI-CPR)

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ClinicalTrials.gov Identifier: NCT02632500
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Robbio nel Cuore
Information provided by (Responsible Party):
Enrico Baldi, Pavia nel Cuore

Brief 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.

Condition or disease Intervention/treatment Phase
Quality of Cardio-pulmonary Resuscitation Other: Quality of chest compressions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multicenter internAtional raNdomized Controlled manIkin Study on Different Protocols of CPR (MANI-CPR)
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 28, 2019
Actual Study Completion Date : April 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR

Arm Intervention/treatment
Experimental: 30 compressions and 2 seconds of pause
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.
Other: Quality of chest compressions
Experimental: 50 compressions and 5 seconds of pauses
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.
Other: Quality of chest compressions
Experimental: 100 compressions and 10 seconds of pause
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.
Other: Quality of chest compressions
Experimental: hands-only
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.
Other: Quality of chest compressions



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Correctly released compressions [ Time Frame: The whole 8 minutes of the performance carried out by each subject. ]
    Differences in the percentage of correctly released compressions among the groups

  2. Compressions with correct hand position [ Time Frame: The whole 8 minutes of the performance carried out by each subject. ]
    Differences in the percentage of compressions with correct hand position among the groups

  3. Number of compressions per minute [ Time Frame: The whole 8 minutes of the performance carried out by each subject. ]
    Difference in the percentage of compressions with correct rythm among the groups

  4. Pauses to rest [ Time Frame: The whole 8 minutes of the performance carried out by each subject. ]
    Lengths of the pauses taken to rest



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Lay people over 18 years old

Exclusion Criteria:

  • Lay people over 80 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632500


Locations
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Italy
Robbio nel Cuore
Robbio, Pavia, Italy, 27038
Policlinico P. Giaccone
Palermo, PA, Italy, 90127
Centro Studi e Formazione Gymnasium
Pordenone, PN, Italy, 33170
Pavia nel Cuore
Pavia, PV, Italy, 27100
Switzerland
FormaMed Sàrl
Cortaillod, Switzerland, 2016
Emergency Training Center
Cugy, Switzerland, 1053
ES ASUR
Le Mont, Switzerland, 1052
FCTSA
Lugano, Switzerland, 6932
Sponsors and Collaborators
Pavia nel Cuore
Robbio nel Cuore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Enrico Baldi, M.D., Pavia nel Cuore
ClinicalTrials.gov Identifier: NCT02632500    
Other Study ID Numbers: ProtocolsCPR
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Keywords provided by Enrico Baldi, Pavia nel Cuore:
Cardio-Pulmonary Resuscitation
Cardiac Arrest
Training