Clinical trial NCT04870736: Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic (MOVE)
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: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Basic Life Support Ventilation
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: 2021-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: medical students trained in BLS as BLS trainers and medical students trained in BLS

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.

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: Incidence of effective mouth-to mouth ventilation
timeFrame: During 2 minute basic life support
Secondary outcomes:
measure: Volumetric analysis of mouth-to-mouth ventilation
timeFrame: During 2 minute basic life support
measure: Impact of training on incidence of effective mouth-to-mouth ventilation
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
state: South Moravian Region
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 Stourac, prof.MD.Ph.D.
role: STUDY_CHAIR
References: