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

NCT ID: NCT04867265

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-03
• Study Completion Date: 2021-06-02

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.

Conditions

Ventilation During Resuscitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan)

medical 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

Group Type: ACTIVE_COMPARATOR

Mout-to-mouth ventilation

Intervention Type: PROCEDURE

we will record the visibility of chest rising

Resusci Anne QCPR AED (Laerdal)

medical 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

Group Type: ACTIVE_COMPARATOR

Mout-to-mouth ventilation

Intervention Type: PROCEDURE

we will record the visibility of chest rising

Mout-to-mouth ventilation with quantitative analysis

Intervention Type: PROCEDURE

we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter

Resusci Baby QCPR (Laerdal)

medical 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

Group Type: ACTIVE_COMPARATOR

Mout-to-mouth ventilation

Intervention Type: PROCEDURE

we will record the visibility of chest rising

Mout-to-mouth ventilation with quantitative analysis

Intervention Type: PROCEDURE

we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter

Interventions

Mout-to-mouth ventilation

we will record the visibility of chest rising

Intervention Type: PROCEDURE

Mout-to-mouth ventilation with quantitative analysis

we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter

Intervention Type: PROCEDURE

Other Intervention Names

Mout-to-mouth ventilation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masaryk University

OTHER

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martina Kosinova, assoc. prof. MD., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicince Masaryk University and University Hospital Brno

Petr Štourač, prof.MD.Ph.D.

Role: STUDY_CHAIR

Faculty of medicince Masaryk University and University Hospital Brno

Locations

Faculty of Medicine, Masaryk University Brno

Brno, , Czechia

Countries

Czechia

Other Identifiers

SIMU 1 2021

Identifier Type: -

Identifier Source: org_study_id