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

May 4, 2019 updated by: Enrico Baldi, Pavia nel Cuore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

576

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PA
      • Palermo, PA, Italy, 90127
        • Policlinico P. Giaccone
    • PN
      • Pordenone, PN, Italy, 33170
        • Centro Studi e Formazione Gymnasium
    • PV
      • Pavia, PV, Italy, 27100
        • Pavia nel Cuore
    • Pavia
      • Robbio, Pavia, Italy, 27038
        • Robbio nel Cuore
  • Switzerland
      • Cortaillod, Switzerland, 2016
        • FormaMed Sàrl
      • Cugy, Switzerland, 1053
        • Emergency Training Center
      • Le Mont, Switzerland, 1052
        • ES ASUR
      • Lugano, Switzerland, 6932
        • FCTSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Lay people over 18 years old

Exclusion Criteria:

  • Lay people over 80 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The whole 8 minutes of the performance carried out by each subject.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Differences in the percentage of compressions with correct hand position among the groups
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.
Difference in the percentage of compressions with correct rythm among the groups
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.
Lengths of the pauses taken to rest
The whole 8 minutes of the performance carried out by each subject.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pavia nel Cuore

Collaborators

Robbio nel Cuore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

April 28, 2019

Study Completion (Actual)

April 28, 2019

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 4, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ProtocolsCPR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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