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Completed

NCT Number: NCT04867265

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

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.

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Key information

Conditions

Ventilation During Resuscitation COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Masaryk University Brno

Brno, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • refusing to participate
  • non-medical students

Treatment and study plan

Mout-to-mouth ventilation

Procedure

we will record the visibility of chest rising

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

Other names: Mout-to-mouth ventilation

Primary outcomes

  1. Mouth-to-mouth ventilation effectivity

    Time frame: During 2 minute basic life support

    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

Secondary outcomes

  1. mouth-to-mouth ventilation volumetric analysis

    Time frame: During 2 minute basic life support

    quantitative data (inspiratory volume) from two mannequins (ResusciAnne, ReusciBaby) using no breath, low, optimal, high volume breath will be evaluated

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

    Time frame: During 2 minute basic life support

    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

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

    Time frame: During 2 minute basic life support

    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)

  4. Correct head position incidence

    Time frame: During 2 minute basic life support

    The head position of the mannequin will be recorded by the observer and compared to the recommended position for the age of the patient

  5. The incidence of ventilation without pinched nose

    Time frame: During 2 minute basic life support

    The incidence of ventilation without pinched nose will be recorded by the observer

  6. Mean breath volume

    Time frame: During 2 minute basic life support

    Mean breath volume during mouth-to-mouth ventilation will be recorded

  7. No-flow interval characteristics

    Time frame: During 2 minute basic life support

    Mean pause and the longest pause in the 2 minutes cycle of basic life support

  8. Adverse events incidence

    Time frame: During 2 minute basic life support

    Incidence of adverse events

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Collaborators

  • Masaryk University

Registry information

Official study title

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

Acronym: MOVERESP

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2021
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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