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

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

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.

Study Overview

• Status: Completed
• Conditions: Simulated Pediatric CRP Ventilation
• Intervention / Treatment: Other: cardiopulmonary resuscitation (CPR)

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).

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Czechia
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 62500
      • Brno University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• not willing to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: Simulation Centre of the Faculty of Medicine of Masaryk University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2022
• Primary Completion (ACTUAL): July 31, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (ACTUAL): April 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pediatric; effectiveness; ventilation; CPR; resuscitation
• Other Study ID Numbers: SIMU 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No