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

NCT ID: NCT05345704

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2022-12-31

Brief Summary

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

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).

Conditions

Simulated Pediatric CRP Ventilation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lay rescuers

Volunteer participants in a role lay rescuers

cardiopulmonary resuscitation (CPR)

Intervention Type: OTHER

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

cardiopulmonary resuscitation (CPR)

Intervention Type: OTHER

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

Interventions

cardiopulmonary resuscitation (CPR)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• not willing to participate

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Simulation Centre of the Faculty of Medicine of Masaryk University

UNKNOWN

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petr Stourac, prof. MD., Ph.D., MBA

Role: STUDY_CHAIR

Department of paediatric anaesthesia and intensive care medicine

Locations

Brno University Hospital

Brno, South Moravian, Czechia

Countries

Czechia

Other Identifiers

SIMU 2022

Identifier Type: -

Identifier Source: org_study_id