Clinical trial NCT05345704: Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation
Official title: Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation in Health Care Professionals and Lay Rescuers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Simulated Pediatric CRP Ventilation
Keywords: CPR
resuscitation
pediatric
ventilation
effectiveness
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Simulation Centre of the Faculty of Medicine of Masaryk University
First posted: 2022-04-26
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteer participants in a role lay rescuers and Health care professionals (HCPs) trained in advanced life support

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* not willing to participate

Primary outcomes:
measure: Initial ventilation effectivity
timeFrame: During 90 seconds of life support
Secondary outcomes:
measure: Delay in ventilation
timeFrame: During 90 seconds of life support
measure: Initial 2 breaths effectivity
timeFrame: During 90 seconds of life support
measure: Initial ventilation adequacy
timeFrame: During 90 seconds of life support
measure: Ventilation volume during initial breaths
timeFrame: During 90 seconds of life support
measure: Delay in CPR
timeFrame: During 90 seconds of life support
measure: CPR description
timeFrame: During 90 seconds of life support
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
affiliation: Department of paediatric anaesthesia and intensive care medicine
name: Petr Stourac, prof. MD., Ph.D., MBA
role: STUDY_CHAIR
References: