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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 31, 2022

Detailed Description

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).

Interventions

  • Other: cardiopulmonary resuscitation (CPR)
    • Data from observation and collected from simulation mannequin during simulated CPR of an infant and child.

Arms, Groups and Cohorts

  • Lay rescuers
    • Volunteer participants in a role lay rescuers
  • Health care professionals (HCPs)
    • Health care professionals (HCPs) trained in advanced life support

Clinical Trial Outcome Measures

Primary Measures

  • Initial ventilation effectivity
    • Time Frame: During 90 seconds of life support
    • 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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Volunteer participants – lay rescuers – Health care professionals performing simulated CPR Exclusion Criteria:

  • not willing to participate

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brno University Hospital
  • Collaborator
    • Simulation Centre of the Faculty of Medicine of Masaryk University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Petr Štourač, MD, Clinical Professor – Brno University Hospital
  • Overall Official(s)
    • Petr Stourac, prof. MD., Ph.D., MBA, Study Chair, Department of paediatric anaesthesia and intensive care medicine

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