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Completed

NCT Number: NCT05345704

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Brno University Hospital

Brno, South Moravian, 62500, Czechia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteer participants - lay rescuers
  • Health care professionals performing simulated CPR

Exclusion criteria

  • not willing to participate

Treatment and study plan

cardiopulmonary resuscitation (CPR)

Other

Data from observation and collected from simulation mannequin during simulated CPR of an infant and child.

Primary outcomes

  1. 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 outcomes

  1. Delay in ventilation

    Time frame: During 90 seconds of life support

    Time to first effective ventilation

  2. Initial 2 breaths effectivity

    Time frame: During 90 seconds of life support

    Number of effective ventilation from first 2 ventilation attempts in each group

  3. 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

  4. Ventilation volume during initial breaths

    Time frame: During 90 seconds of life support

    Percentage of correct volume breaths during CPR

  5. Delay in CPR

    Time frame: During 90 seconds of life support

    Time to start of chest compressions

  6. CPR description

    Time frame: During 90 seconds of life support

    Number of CPR cycles (15 compressions: 2 ventilations) during 90 seconds of simulated CPR

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Collaborators

  • Simulation Centre of the Faculty of Medicine of Masaryk University

Registry information

Official study title

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

Acronym: PEDIVENT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2022
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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