Simulated Pediatric CRP VentilationPEDIVENTNCT05345704
Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation
An observational study of Simulated Pediatric CRP Ventilation, run by Brno University Hospital at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Simulated Pediatric CRP Ventilation
- What is being tested?
- cardiopulmonary resuscitation (CPR)
- How many people
- 86 participants
- Where
- 1 siteCzechia
- Study dates
- 28 Apr 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Volunteer participants in a role lay rescuers and Health care professionals (HCPs) trained in advanced life support
Who may be able to join
- Volunteer participants - lay rescuers
- Health care professionals performing simulated CPR
Who cannot join
- not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- cardiopulmonary resuscitation (CPR)
- Keywords
- CPR, resuscitation, pediatric, ventilation, effectiveness
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary resuscitation (CPR)Other
Data from observation and collected from simulation mannequin during simulated CPR of an infant and child.
| Study group | Role | What they receive |
|---|---|---|
| Lay rescuers | Volunteer participants in a role lay rescuers Receives: Other: cardiopulmonary resuscitation (CPR) | |
| Health care professionals (HCPs) | Health care professionals (HCPs) trained in advanced life support Receives: Other: cardiopulmonary resuscitation (CPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During 90 seconds of life support
Secondary outcomes (6)
Delay in ventilation
Time to first effective ventilation
Measured: During 90 seconds of life support
Initial 2 breaths effectivity
Number of effective ventilation from first 2 ventilation attempts in each group
Measured: 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
Measured: During 90 seconds of life support
Ventilation volume during initial breaths
Percentage of correct volume breaths during CPR
Measured: During 90 seconds of life support
Delay in CPR
Time to start of chest compressions
Measured: During 90 seconds of life support
CPR description
Number of CPR cycles (15 compressions: 2 ventilations) during 90 seconds of simulated CPR
Measured: During 90 seconds of life support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start28 Apr 2022
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulated Pediatric CRP VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Simulation Centre of the Faculty of Medicine of Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., MBA, Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345704
- Sponsor's protocol ID
- SIMU 2022
- Acronym
- PEDIVENT
- Status last verified
- Feb 2023
- First submitted
- 10 Apr 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Comparative Study on Efficiency of Ventilation During Paediatric Cardiopulmonary Resuscitation in Health Care Professionals and Lay Rescuers
- ClinicalTrials.gov ID
- NCT05345704
- Acronym / sponsor ID
- PEDIVENT / SIMU 2022
- Conditions
- Simulated Pediatric CRP Ventilation
- Keywords
- CPR, resuscitation, pediatric, ventilation, effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Simulation Centre of the Faculty of Medicine of Masaryk University
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lay rescuers | – | Other: cardiopulmonary resuscitation (CPR)Volunteer participants in a role lay rescuers |
| Health care professionals (HCPs) | – | Other: cardiopulmonary resuscitation (CPR)Health care professionals (HCPs) trained in advanced life support |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Volunteer participants in a role lay rescuers and Health care professionals (HCPs) trained in advanced life support
Key inclusion criteria (2 listed)
- Volunteer participants - lay rescuers
- Health care professionals performing simulated CPR
Key exclusion criteria (1 listed)
- not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiopulmonary resuscitation (CPR)Data from observation and collected from simulation mannequin during simulated CPR of an infant and child. | Other | Health care professionals (HCPs), Lay rescuers |
Primary outcome
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
6 secondary outcomes
Delay in ventilation
Time frame: During 90 seconds of life support
Initial 2 breaths effectivity
Time frame: During 90 seconds of life support
Initial ventilation adequacy
Time frame: During 90 seconds of life support
Ventilation volume during initial breaths
Time frame: During 90 seconds of life support
Delay in CPR
Time frame: During 90 seconds of life support
CPR description
Time frame: During 90 seconds of life support
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Stourac, prof. MD., Ph.D., MBA study chair
Department of paediatric anaesthesia and intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Simulated Pediatric CRP Ventilation, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial ventilation effectivity (time frame: During 90 seconds of life support). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.