Clinical trial NCT04867265: Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic
Official title: Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic: a Crossover Simulation-based Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation During Resuscitation
Keywords: Basic life support
COVID-19
Self-sterilizing nanofiber respirator
Mouth-to-mouth ventilation
Efficiency
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2021-04-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* refusing to participate
* non-medical students

Primary outcomes:
measure: Mouth-to-mouth ventilation effectivity
timeFrame: During 2 minute basic life support
Secondary outcomes:
measure: mouth-to-mouth ventilation volumetric analysis
timeFrame: During 2 minute basic life support
measure: medical students trained as BLS trainers versus medical students trained in BLS mouth-to-mouth breathing efficacy
timeFrame: During 2 minute basic life support
measure: Overall quantitative volumetric efficacy of mouth-to-mouth breathing between the medical students trained as BLS trainers versus medical students trained in BLS
timeFrame: During 2 minute basic life support
measure: Correct head position incidence
timeFrame: During 2 minute basic life support
measure: The incidence of ventilation without pinched nose
timeFrame: During 2 minute basic life support
measure: Mean breath volume
timeFrame: During 2 minute basic life support
measure: No-flow interval characteristics
timeFrame: During 2 minute basic life support
measure: Adverse events incidence
timeFrame: During 2 minute basic life support
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Faculty of Medicine, Masaryk University Brno
Study officials:
affiliation: Faculty of medicince Masaryk University and University Hospital Brno
name: Martina Kosinova, assoc. prof. MD., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of medicince Masaryk University and University Hospital Brno
name: Petr Štourač, prof.MD.Ph.D.
role: STUDY_CHAIR
References: