NCT05345704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

April 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

April 10, 2022

Last Update Submit

February 10, 2023

Conditions

Keywords

CPRresuscitationpediatricventilationeffectiveness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Delay in ventilation

    During 90 seconds of life support

  • Initial 2 breaths effectivity

    During 90 seconds of life support

  • Initial ventilation adequacy

    During 90 seconds of life support

  • Ventilation volume during initial breaths

    During 90 seconds of life support

  • Delay in CPR

    During 90 seconds of life support

  • +1 more secondary outcomes

Study Arms (2)

Lay rescuers

Volunteer participants in a role lay rescuers

Other: cardiopulmonary resuscitation (CPR)

Health care professionals (HCPs)

Health care professionals (HCPs) trained in advanced life support

Other: cardiopulmonary resuscitation (CPR)

Interventions

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

Health care professionals (HCPs)Lay rescuers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Study Officials

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

    Department of paediatric anaesthesia and intensive care medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 10, 2022

First Posted

April 26, 2022

Study Start

April 28, 2022

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations