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

Primary Purpose

Ventilation During Resuscitation

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Mout-to-mouth ventilation
Mout-to-mouth ventilation with quantitative analysis
Sponsored by
Brno University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ventilation During Resuscitation focused on measuring Basic life support, COVID-19, Self-sterilizing nanofiber respirator, Mouth-to-mouth ventilation, Efficiency

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • medical students trained in BLS as BLS trainers
  • medical students trained in BLS

Exclusion Criteria:

  • refusing to participate
  • non-medical students

Sites / Locations

  • Faculty of Medicine, Masaryk University Brno

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

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

Resusci Anne QCPR AED (Laerdal)

Resusci Baby QCPR (Laerdal)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Mouth-to-mouth ventilation effectivity
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

mouth-to-mouth ventilation volumetric analysis
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 efficacy
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 BLS
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 incidence
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 nose
The incidence of ventilation without pinched nose will be recorded by the observer
Mean breath volume
Mean breath volume during mouth-to-mouth ventilation will be recorded
No-flow interval characteristics
Mean pause and the longest pause in the 2 minutes cycle of basic life support
Adverse events incidence
Incidence of adverse events

Full Information

First Posted
April 26, 2021
Last Updated
June 2, 2021
Sponsor
Brno University Hospital
Collaborators
Masaryk University
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1. Study Identification

Unique Protocol Identification Number
NCT04867265
Brief Title
Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic
Acronym
MOVERESP
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brno University Hospital
Collaborators
Masaryk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilation During Resuscitation
Keywords
Basic life support, COVID-19, Self-sterilizing nanofiber respirator, Mouth-to-mouth ventilation, Efficiency

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Resusci Anne QCPR AED (Laerdal)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Resusci Baby QCPR (Laerdal)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Mout-to-mouth ventilation
Intervention Description
we will record the visibility of chest rising
Intervention Type
Procedure
Intervention Name(s)
Mout-to-mouth ventilation with quantitative analysis
Other Intervention Name(s)
Mout-to-mouth ventilation
Intervention Description
we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter
Primary Outcome Measure Information:
Title
Mouth-to-mouth ventilation effectivity
Description
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
Time Frame
During 2 minute basic life support
Secondary Outcome Measure Information:
Title
mouth-to-mouth ventilation volumetric analysis
Description
quantitative data (inspiratory volume) from two mannequins (ResusciAnne, ReusciBaby) using no breath, low, optimal, high volume breath will be evaluated
Time Frame
During 2 minute basic life support
Title
medical students trained as BLS trainers versus medical students trained in BLS mouth-to-mouth breathing efficacy
Description
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
Time Frame
During 2 minute basic life support
Title
Overall quantitative volumetric efficacy of mouth-to-mouth breathing between the medical students trained as BLS trainers versus medical students trained in BLS
Description
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)
Time Frame
During 2 minute basic life support
Title
Correct head position incidence
Description
The head position of the mannequin will be recorded by the observer and compared to the recommended position for the age of the patient
Time Frame
During 2 minute basic life support
Title
The incidence of ventilation without pinched nose
Description
The incidence of ventilation without pinched nose will be recorded by the observer
Time Frame
During 2 minute basic life support
Title
Mean breath volume
Description
Mean breath volume during mouth-to-mouth ventilation will be recorded
Time Frame
During 2 minute basic life support
Title
No-flow interval characteristics
Description
Mean pause and the longest pause in the 2 minutes cycle of basic life support
Time Frame
During 2 minute basic life support
Title
Adverse events incidence
Description
Incidence of adverse events
Time Frame
During 2 minute basic life support

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Kosinova, assoc. prof. MD., Ph.D.
Organizational Affiliation
Faculty of medicince Masaryk University and University Hospital Brno
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petr Štourač, prof.MD.Ph.D.
Organizational Affiliation
Faculty of medicince Masaryk University and University Hospital Brno
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, Masaryk University Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia

12. IPD Sharing Statement

Learn more about this trial

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

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