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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 with CPR Monitor (Prestan), Resusci Anne QCPR AED (Laerdal), Resusci Baby QCPR (Laerdal). 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 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.

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

Conditions
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Ventilation During Resuscitation

Intervention / Treatment
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* Procedure: Mout-to-mouth ventilation
* Procedure: Mout-to-mouth ventilation with quantitative analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medical students trained in BLS as BLS trainers medical students trained in BLS Exclusion Criteria: refusing to participate non-medical students

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan)<br>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<br>* we will record the visibility of chest rising<br>|
| Active Comparator: Resusci Anne QCPR AED (Laerdal)<br>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<br>* we will record the visibility of chest rising<br>Procedure: Mout-to-mouth ventilation with quantitative analysis<br>* we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter<br>* Other names: Mout-to-mouth ventilation;|
| Active Comparator: Resusci Baby QCPR (Laerdal)<br>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<br>* we will record the visibility of chest rising<br>Procedure: Mout-to-mouth ventilation with quantitative analysis<br>* we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter<br>* Other names: Mout-to-mouth ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mouth-to-mouth ventilation volumetric analysis | 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 | 
| medical students trained as BLS trainers versus medical students trained in BLS mouth-to-mouth breathing efficacy | 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 breathnig) vs. visible breath (chest rising) on all three mannequins will be evaluated | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Basic life support, COVID-19, Self-sterilizing nanofiber respirator, Mouth-to-mouth ventilation, Efficiency