NCT04870736

Brief Summary

Complex practical basic life support (BLS) training have been stopped all over the world due to coronavirus disease (COVID-19) pandemic in 2020. While launching the new Simulation Centre at Medical Faculty of Masaryk University in Brno, Czech Republic, teachers and students have been dealing with the risk of COVID-19 transmission during the simulation training. One of the highest risks for the transfer of COVID-19 between the medical students is during the mouth-to-mouth ventilation training in BLS. It has been assumed that rescuers during BLS simulation training with use of breathable nanofiber respirator with layers with accelerated copper can provide efficient mouth-to-mouth rescue breaths to the mannequin in compliance with safety rules.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

April 29, 2021

Last Update Submit

April 30, 2021

Conditions

Keywords

Basic life supportCOVID-19Self-sterilizing nanofiber respiratorMouth-to-mouth ventilationEfficiency

Outcome Measures

Primary Outcomes (1)

  • Incidence of effective mouth-to mouth ventilation

    data from all three mannequins using variables as: No breath (chest not rising) or Visible breath (chest rising) value will be used to evaluate the overall efficacy of mouth-to-mouth ventilation

    During 2 minute basic life support

Secondary Outcomes (8)

  • Volumetric analysis of mouth-to-mouth ventilation

    During 2 minute basic life support

  • Impact of training on incidence of effective mouth-to-mouth ventilation

    During 2 minute basic life support

  • Overall quantitative volumetric efficacy of mouth-to-mouth breathing between the medical students trained as BLS trainers versus medical students trained in BLS

    During 2 minute basic life support

  • Correct head position incidence

    During 2 minute basic life support

  • The incidence of ventilation without pinched nose

    During 2 minute basic life support

  • +3 more secondary outcomes

Study Arms (3)

Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan)

medical students trained as BLS trainers and medical students trained in BLS will provide 2 minutes cycle of BLS according to ERC guidelines 2021 wearing the breathable self-sterilizing nanofiber respirators with accelerated copper

Procedure: Mout-to-mouth ventilation

Resusci Anne QCPR AED (Laerdal)

medical students trained as BLS trainers and medical students trained in BLS will provide 2 minutes cycle of BLS according to ERC guidelines 2021 wearing the breathable self-sterilizing nanofiber respirators with accelerated copper

Procedure: Mout-to-mouth ventilationProcedure: Mout-to-mouth ventilation with quantitative analysis

Resusci Baby QCPR (Laerdal)

medical students trained as BLS trainers and medical students trained in BLS will provide 2 minutes cycle of BLS according to ERC guidelines 2021 wearing the breathable self-sterilizing nanofiber respirators with accelerated copper

Procedure: Mout-to-mouth ventilationProcedure: Mout-to-mouth ventilation with quantitative analysis

Interventions

Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.

Also known as: Basic life support ventilation
Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan)Resusci Anne QCPR AED (Laerdal)Resusci Baby QCPR (Laerdal)

Chest rising during basic life support will be recorded and evaluated (breath by breath) in QCPR Skill Reporter software

Also known as: Basic life support ventilation with quantitative analysis
Resusci Anne QCPR AED (Laerdal)Resusci Baby QCPR (Laerdal)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

medical students trained in BLS as BLS trainers and medical students trained in BLS

You may qualify if:

  • medical students trained in BLS as BLS trainers
  • medical students trained in BLS

You may not qualify if:

  • refusing to participate
  • non-medical students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Masaryk University Brno

Brno, South Moravian, 62500, Czechia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Martina Kosinova, assoc. prof. MD., Ph.D.

    Faculty of medicince Masaryk University and University Hospital Brno

    PRINCIPAL INVESTIGATOR
  • Petr Stourac, prof.MD.Ph.D.

    Faculty of medicince Masaryk University and University Hospital Brno

    STUDY CHAIR
0

Study Design

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

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 3, 2021

Study Start

May 3, 2021

Primary Completion

June 30, 2021

Study Completion

September 1, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations