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

• ClinicalTrials.gov Identifier: NCT04870736
• Recruitment Status: Withdrawn
• First Posted: May 3, 2021
• Last Update Posted: May 3, 2021
• Sponsor: Brno University Hospital
• Collaborator: Medical Faculty of Masaryk University, Brno, Czech Republic
• Information provided by (Responsible Party): Petr Štourač, MD, Brno University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Basic Life Support Ventilation	Procedure: Mout-to-mouth ventilation; Procedure: Mout-to-mouth ventilation with quantitative analysis

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic: a Crossover Simulation-based Study
• Estimated Study Start Date: May 3, 2021
• Estimated Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: September 1, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan); medical students trained as 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	Procedure: Mout-to-mouth ventilation; Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.; Other Name: Basic life support ventilation
Resusci Anne QCPR AED (Laerdal); medical students trained as 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	Procedure: Mout-to-mouth ventilation; Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.; Other Name: Basic life support ventilation; Procedure: Mout-to-mouth ventilation with quantitative analysis; Chest rising during basic life support will be recorded and evaluated (breath by breath) in QCPR Skill Reporter software; Other Name: Basic life support ventilation with quantitative analysis
Resusci Baby QCPR (Laerdal); medical students trained as 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	Procedure: Mout-to-mouth ventilation; Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.; Other Name: Basic life support ventilation; Procedure: Mout-to-mouth ventilation with quantitative analysis; Chest rising during basic life support will be recorded and evaluated (breath by breath) in QCPR Skill Reporter software; Other Name: Basic life support ventilation with quantitative analysis

Outcome Measures

Primary Outcome Measures :

1. Incidence of effective mouth-to mouth ventilation [ Time Frame: During 2 minute basic life support ]
   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 :

1. Volumetric analysis of mouth-to-mouth ventilation [ Time Frame: During 2 minute basic life support ]
   quantitative data (inspiratory volume) from two mannequins (ResusciAnne, ReusciBaby) using no breath, low, optimal, high volume breath will be evaluated
2. Impact of training on incidence of effective mouth-to-mouth ventilation [ Time Frame: During 2 minute basic life support ]
   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 breathing) vs. visible breath (chest rising) on all three mannequins will be evaluated
3. Overall quantitative volumetric efficacy of mouth-to-mouth breathing between the medical students trained as BLS trainers versus medical students trained in BLS [ Time Frame: During 2 minute basic life support ]
   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)
4. Correct head position incidence [ Time Frame: During 2 minute basic life support ]
   The head position of the mannequin will be recorded by the observer and compared to the recommended position for the age of the patient
5. The incidence of ventilation without pinched nose [ Time Frame: During 2 minute basic life support ]
   The incidence of ventilation without pinched nose will be recorded by the observer
6. Mean breath volume [ Time Frame: During 2 minute basic life support ]
   Mean breath volume during mouth-to-mouth ventilation will be recorded
7. No-flow interval characteristics [ Time Frame: During 2 minute basic life support ]
   Mean pause and the longest pause in the 2 minutes cycle of basic life support
8. Adverse events incidence [ Time Frame: During 2 minute basic life support ]
   Incidence of adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

medical students trained in BLS as BLS trainers and medical students trained in BLS

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• refusing to participate
• non-medical students

Contacts and Locations

Locations

Czechia

Faculty of Medicine, Masaryk University Brno

Brno, South Moravian Region, Czechia, 62500

Sponsors and Collaborators

Brno University Hospital

Medical Faculty of Masaryk University, Brno, Czech Republic

Investigators

• Principal Investigator: Martina Kosinova, assoc. prof. MD., Ph.D.; Faculty of medicince Masaryk University and University Hospital Brno
• Study Chair: Petr Stourac, prof.MD.Ph.D.; Faculty of medicince Masaryk University and University Hospital Brno

More Information

• Responsible Party: Petr Štourač, MD, Clinical Professor, Brno University Hospital
• ClinicalTrials.gov Identifier: NCT04870736
• Other Study ID Numbers: SIMU 2 2021
• First Posted: May 3, 2021
• Last Update Posted: May 3, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Petr Štourač, MD, Brno University Hospital:

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

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases