Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic

NCT04867265 | Completed

• 1 other identifier: SIMU 1 2021
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Complex practical BLS training have been stopped all over the world due to 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.

Conditions

Ventilation During Resuscitation

Keywords

Basic life support; COVID-19; Self-sterilizing nanofiber respirator; Mouth-to-mouth ventilation; Efficiency

Outcome Measures

Primary Outcomes (1)

• Mouth-to-mouth ventilation effectivity

  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)

• mouth-to-mouth ventilation volumetric analysis

  During 2 minute basic life support

• medical students trained as BLS trainers versus medical students trained in BLS mouth-to-mouth breathing efficacy

  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

Study Arms (3)

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

ACTIVE COMPARATOR

medical students trained 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)

ACTIVE COMPARATOR

medical students trained 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; Procedure: Mout-to-mouth ventilation with quantitative analysis

Resusci Baby QCPR (Laerdal)

ACTIVE COMPARATOR

medical students trained 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; Procedure: Mout-to-mouth ventilation with quantitative analysis

Interventions

Mout-to-mouth ventilation PROCEDURE

we will record the visibility of chest rising

Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan); Resusci Anne QCPR AED (Laerdal); Resusci Baby QCPR (Laerdal)

Mout-to-mouth ventilation with quantitative analysis PROCEDURE

we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter

Also known as: Mout-to-mouth ventilation

Resusci Anne QCPR AED (Laerdal); Resusci Baby QCPR (Laerdal)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Brno University Hospital: lead
• Masaryk University: collaborator

Study Sites (1)

Faculty of Medicine, Masaryk University Brno

Brno, 62500, Czechia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

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

  Faculty of medicince Masaryk University and University Hospital Brno

  PRINCIPAL INVESTIGATOR

• Petr Štourač, prof.MD.Ph.D.

  Faculty of medicince Masaryk University and University Hospital Brno

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Medical students trained as BLS providers (first group) and Medical student trained as teachers will perform mouth-to-mouth ventilation in 3 case scenarios on 3 different mannequins.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 30, 2021
• Study Start: May 3, 2021
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-06

Locations

CZ (1)