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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04870736
Acronym
MOVE
Enrollment
0
Registered
2021-05-03
Start date
2021-05-03
Completion date
2021-09-01
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basic Life Support Ventilation

Keywords

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

Brief summary

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.

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.

Interventions

Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.

Chest rising during basic life support will be recorded and evaluated (breath by breath) in QCPR Skill Reporter software

Sponsors

Masaryk University
CollaboratorOTHER
Brno University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* medical students trained in BLS as BLS trainers * medical students trained in BLS

Exclusion criteria

* refusing to participate * non-medical students

Design outcomes

Primary

MeasureTime frameDescription
Incidence of effective mouth-to mouth ventilationDuring 2 minute basic life supportdata 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

MeasureTime frameDescription
Impact of training on incidence of effective mouth-to-mouth ventilationDuring 2 minute basic life supportOverall 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
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 supportOverall 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 supportThe head position of the mannequin will be recorded by the observer and compared to the recommended position for the age of the patient
Volumetric analysis of mouth-to-mouth ventilationDuring 2 minute basic life supportquantitative data (inspiratory volume) from two mannequins (ResusciAnne, ReusciBaby) using no breath, low, optimal, high volume breath will be evaluated
Mean breath volumeDuring 2 minute basic life supportMean breath volume during mouth-to-mouth ventilation will be recorded
No-flow interval characteristicsDuring 2 minute basic life supportMean pause and the longest pause in the 2 minutes cycle of basic life support
Adverse events incidenceDuring 2 minute basic life supportIncidence of adverse events
The incidence of ventilation without pinched noseDuring 2 minute basic life supportThe incidence of ventilation without pinched nose will be recorded by the observer

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026