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

Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic: a Crossover Simulation-based Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Basic Life Support Ventilation
• Intervention / Treatment: Procedure: Mout-to-mouth ventilation; Procedure: Mout-to-mouth ventilation with quantitative analysis

Detailed Description

The main aim of this study is to assess the efficiency of mouth-to-mouth ventilation through breathable self-sterilizing nanofiber respirators with accelerated copper in COVID-19 pandemic time. 100 volunteers (medical students trained as BLS trainers an medical students trained in BLS) will provide 2 minutes cycle of BLS according to European Resuscitation Council (ERC) guidelines 2021 wearing the breathable self-sterilizing nanofiber respirators with accelerated copper in three different mannequins: Professional Adult Medium Skin CPR-AED Training Manikin (trademark) with CPR Monitor (Prestan = trademark), Resusci Anne QCPR AED (Laerdal = trademark), Resusci Baby QCPR (Laerdal = trademark). The mannequin will be utilised in a randomised order. The efficiency of mouth-to-mouth rescue breaths as "visible breath " and "not visible breath" will be recorded. In first BLS mannequin, the visibility of chest rising by the observer will be recorded. In two other mannequins, the ventilation metrics and each rescue breath evaluation in QCPR Skill Reporter (software trademark) will be recorded. Overall, 3 levels of visible breath according to the relation to set optimal breath volume (400 to 600 mL in adult, 30 to 50 mL in infant): low volume breath (below 400ml in adults and below 30ml in infant), optimal volume breath (between 400-600ml in adult and between 30-50 ml in infant), high volume breath (over 600ml in adult and over 50ml in infant) will be evaluated. For the primary analysis of efficiency of mouth-to-mouth ventilation, data from all three mannequins using outcome No breath / Visible breath will be evaluated. Secondary analysis will utilize data from two mannequins where detailed stratification No Breath / low / optimal / high Visible breath is possible. The mean volume of rescue breaths in the 2-minute cycle, average pause, longest pause, success in achieving the optimal breath volume, adverse events will be recorded. Regarding the technique of provided mouth-to-mouth ventilation, head tilt in adult or neutral position in infant and pinching of the nose will be evaluated.

• Study Type: Observational

Contacts and Locations

Study Locations

• Czechia
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 62500
      • Faculty of Medicine, Masaryk University Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• refusing to participate
• non-medical students

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.; Other Names: Basic life support 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 ventilation; Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.; Other Names: Basic life support ventilation; Procedure: Mout-to-mouth ventilation with quantitative analysis; Chest rising during basic life support will be recorded and evaluated (breath by breath) in QCPR Skill Reporter software; Other Names: Basic life support 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 ventilation; Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.; Other Names: Basic life support ventilation; Procedure: Mout-to-mouth ventilation with quantitative analysis; Chest rising during basic life support will be recorded and evaluated (breath by breath) in QCPR Skill Reporter software; Other Names: Basic life support ventilation with quantitative analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall quantitative volumetric efficacy of mouth-to-mouth breathing between the medical students trained as BLS trainers versus medical students trained in BLS	Overall quantitative efficacy of mouth-to-mouth breathing of medical students trained as BLS trainers versus medical students trained in BLS will be compared taking into account no breath vs. low vs. optimal vs. high volume breath on two mannequins with the possibility of quantitative analysis (ResusiceAnne, ResusciBaby)	During 2 minute basic life support
Correct head position incidence	The head position of the mannequin will be recorded by the observer and compared to the recommended position for the age of the patient	During 2 minute basic life support
The incidence of ventilation without pinched nose	The incidence of ventilation without pinched nose will be recorded by the observer	During 2 minute basic life support
Mean breath volume	Mean breath volume during mouth-to-mouth ventilation will be recorded	During 2 minute basic life support
No-flow interval characteristics	Mean pause and the longest pause in the 2 minutes cycle of basic life support	During 2 minute basic life support
Adverse events incidence	Incidence of adverse events	During 2 minute basic life support
Volumetric analysis of mouth-to-mouth ventilation	quantitative data (inspiratory volume) from two mannequins (ResusciAnne, ReusciBaby) using no breath, low, optimal, high volume breath will be evaluated	During 2 minute basic life support
Impact of training on incidence of effective mouth-to-mouth ventilation	Overall efficacy of medical students trained as BLS trainers versus medical students trained in BLS will be compared taking into account no breath (chest not rising during breathing) vs. visible breath (chest rising) on all three mannequins will be evaluated	During 2 minute basic life support

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: Masaryk University
• Investigators: Study Chair: Petr Stourac, prof.MD.Ph.D., Faculty of medicince Masaryk University and University Hospital Brno; Principal Investigator: Martina Kosinova, assoc. prof. MD., Ph.D., Faculty of medicince Masaryk University and University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Anticipated): May 3, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Basic life support; Efficiency; Self-sterilizing nanofiber respirator; Mouth-to-mouth ventilation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SIMU 2 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No