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

Not Applicable
Completed
Conditions
Ventilation During Resuscitation
Interventions
Procedure: Mout-to-mouth ventilation
Procedure: Mout-to-mouth ventilation with quantitative analysis
Registration Number
NCT04867265
Lead Sponsor
Brno University Hospital
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.

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 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
104
Inclusion Criteria
  • medical students trained in BLS as BLS trainers
  • medical students trained in BLS
Exclusion Criteria
  • refusing to participate
  • non-medical students

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan)Mout-to-mouth ventilationmedical 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
Resusci Anne QCPR AED (Laerdal)Mout-to-mouth ventilationmedical 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
Resusci Anne QCPR AED (Laerdal)Mout-to-mouth ventilation with quantitative analysismedical 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
Resusci Baby QCPR (Laerdal)Mout-to-mouth ventilationmedical 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
Resusci Baby QCPR (Laerdal)Mout-to-mouth ventilation with quantitative analysismedical 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
Primary Outcome Measures
NameTimeMethod
Mouth-to-mouth ventilation effectivityDuring 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 Outcome Measures
NameTimeMethod
Adverse events incidenceDuring 2 minute basic life support

Incidence of adverse events

mouth-to-mouth ventilation volumetric analysisDuring 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

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

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

Correct head position incidenceDuring 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

The incidence of ventilation without pinched noseDuring 2 minute basic life support

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

Mean breath volumeDuring 2 minute basic life support

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

No-flow interval characteristicsDuring 2 minute basic life support

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

Trial Locations

Locations (1)

Faculty of Medicine, Masaryk University Brno

🇨🇿

Brno, Czechia

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