Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation

Study Overview
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Brief Summary
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The aim of this study is to gather data to support beginning the pediatric cardiopulmonary resuscitation (CPR) with 5 initial breaths. The group of health care professionals and the group lay rescuers will be asked to perform cardiopulmonary resuscitation (CRP) on 2 pediatric simulation mannequins (the 3-month-old infant, 5 kg, and the 5-year-old child, 25 kg) and the effectiveness of initial ventilation attempts will be evaluated.

Detailed Description
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There is a lack of knowledge on the efficiency of ventilation during simulated and real cardiopulmonary resuscitation of children and infants. The ventilations should be an integral part of pediatric resuscitation as recommended by European Resuscitation Council (ERC) because the respiratory and other secondary causes with oxygen depletion are common causes of cardiac arrest in children. However, the effectiveness and quality of ventilation are rarely studied and ERC guidelines to start ventilation with 5 initial breaths in pediatric CPR are based on the experts´ opinion. This study evaluates ventilation efficiency during simulated pediatric cardiopulmonary resuscitation performed by 2 different groups of potential rescuers - physicians, nurses- representing the advanced life support and lay rescuers- representing the basic life support algorithm. The primary aim of this study is to evaluate the number of effective breaths (define as a visible chest rise) during 5 initial breaths attempts of simulated pediatric cardiopulmonary resuscitation. Secondary outcomes include subanalysis of the effectiveness of two initial breaths attempts, defined as a visible chest rise, time to first effective breath, breath volume delivered during 5 initial breaths, and breaths during CPR. The appropriate volume would be considered 6-10 mL/kg (i.e. 30 - 50 mL in infant and 125- 250 mL in the child). The data will be obtained before and after standardized simulation training in both groups. For lay rescuers, the dispatcher-assisted CPR will be simulated. For the health care professionals, basic equipment will be available and expected to be used (correct size mask and bag-mask ventilation).

Official Title
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Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation in Health Care Professionals and Lay Rescuers

Conditions
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Simulated Pediatric CRP Ventilation

Intervention / Treatment
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* Other: cardiopulmonary resuscitation (CPR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteer participants - lay rescuers Health care professionals performing simulated CPR Exclusion Criteria: not willing to participate
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lay rescuers<br>Volunteer participants in a role lay rescuers | Other: cardiopulmonary resuscitation (CPR)<br>* Data from observation and collected from simulation mannequin during simulated CPR of an infant and child.<br>|
| Health care professionals (HCPs)<br>Health care professionals (HCPs) trained in advanced life support | Other: cardiopulmonary resuscitation (CPR)<br>* Data from observation and collected from simulation mannequin during simulated CPR of an infant and child.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial ventilation effectivity | Number of ventilations that are effective out of the first 5 attempts in each group. Defined as breath that has the ability to elevate the chest | During 90 seconds of life support | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay in ventilation | Time to first effective ventilation | During 90 seconds of life support | 
| Initial 2 breaths effectivity | Number of effective ventilation from first 2 ventilation attempts in each group | During 90 seconds of life support | 
| Initial ventilation adequacy | Number of ventilations with correct volumes (6-8 mL/kg) out of the first 5 attempts | During 90 seconds of life support | 
| Ventilation volume during initial breaths | Percentage of correct volume breaths during CPR | During 90 seconds of life support | 
| Delay in CPR | Time to start of chest compressions | During 90 seconds of life support | 
| CPR description | Number of CPR cycles (15 compressions: 2 ventilations) during 90 seconds of simulated CPR | During 90 seconds of life support | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPR, resuscitation, pediatric, ventilation, effectiveness