Basic Life Support VentilationMOVENCT04870736
Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic (MOVE)
An observational study of Basic Life Support Ventilation, run by Brno University Hospital at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Life Support Ventilation
- What is being tested?
- Mout-to-mouth ventilation and Mout-to-mouth ventilation with quantitative analysis
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteCzechia
- Study dates
- 3 May 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: medical students trained in BLS as BLS trainers and medical students trained in BLS
Who may be able to join
- medical students trained in BLS as BLS trainers
- medical students trained in BLS
Who cannot join
- refusing to participate
- non-medical students
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Faculty of Medicine, Masaryk University Brno
Brno, South Moravian, 62500
About this study
Official title: Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic: a Crossover Simulation-based Study
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.
Read the 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.
- Conditions
- Basic Life Support Ventilation
- Being tested
- Mout-to-mouth ventilation, Mout-to-mouth ventilation with quantitative analysis
- Keywords
- Basic life support, COVID-19, Self-sterilizing nanofiber respirator, Mouth-to-mouth ventilation, Efficiency
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mout-to-mouth ventilationProcedure or surgery
Also called Basic life support ventilation
Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.
Mout-to-mouth ventilation with quantitative analysisProcedure or surgery
Also called Basic life support ventilation with quantitative analysis
Chest rising during basic life support will be recorded and evaluated (breath by breath) in QCPR Skill Reporter software
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Mout-to-mouth 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 Receives: Procedure: Mout-to-mouth ventilation; Procedure: Mout-to-mouth 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 Receives: Procedure: Mout-to-mouth ventilation; Procedure: Mout-to-mouth ventilation with quantitative analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of effective mouth-to mouth ventilation
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
Measured: During 2 minute basic life support
Secondary outcomes (8)
Volumetric analysis of mouth-to-mouth ventilation
quantitative data (inspiratory volume) from two mannequins (ResusciAnne, ReusciBaby) using no breath, low, optimal, high volume breath will be evaluated
Measured: During 2 minute basic life support
Impact of training on incidence of effective mouth-to-mouth ventilation
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
Measured: During 2 minute basic life support
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)
Measured: During 2 minute basic life support
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
Measured: During 2 minute basic life support
The incidence of ventilation without pinched nose
The incidence of ventilation without pinched nose will be recorded by the observer
Measured: During 2 minute basic life support
Mean breath volume
Mean breath volume during mouth-to-mouth ventilation will be recorded
Measured: During 2 minute basic life support
No-flow interval characteristics
Mean pause and the longest pause in the 2 minutes cycle of basic life support
Measured: During 2 minute basic life support
Adverse events incidence
Incidence of adverse events
Measured: During 2 minute basic life support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start3 May 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Why it stopped: Duplication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic Life Support VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Martina Kosinova, assoc. prof. MD., Ph.D., Principal investigator, Faculty of medicince Masaryk University and University Hospital BrnoPetr Stourac, prof.MD.Ph.D., Study chair, Faculty of medicince Masaryk University and University Hospital Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870736
- Sponsor's protocol ID
- SIMU 2 2021
- Acronym
- MOVE
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic: a Crossover Simulation-based Study
- ClinicalTrials.gov ID
- NCT04870736
- Acronym / sponsor ID
- MOVE / SIMU 2 2021
- Conditions
- Basic Life Support Ventilation
- Keywords
- Basic life support, COVID-19, Self-sterilizing nanofiber respirator, Mouth-to-mouth ventilation, Efficiency
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Duplication
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 3 May 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan) | – | Procedure: Mout-to-mouth ventilationmedical 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 |
| Resusci Anne QCPR AED (Laerdal) | – | Procedure: Mout-to-mouth ventilation, Procedure: Mout-to-mouth ventilation with quantitative analysismedical 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 |
| Resusci Baby QCPR (Laerdal) | – | Procedure: Mout-to-mouth ventilation, Procedure: Mout-to-mouth ventilation with quantitative analysismedical 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- medical students trained in BLS as BLS trainers and medical students trained in BLS
Key inclusion criteria (2 listed)
- medical students trained in BLS as BLS trainers
- medical students trained in BLS
Key exclusion criteria (2 listed)
- refusing to participate
- non-medical students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mout-to-mouth ventilationAlso: Basic life support ventilationChest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer. | Procedure or surgery | Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan), Resusci Anne QCPR AED (Laerdal), Resusci Baby QCPR (Laerdal) |
| Mout-to-mouth ventilation with quantitative analysisAlso: Basic life support ventilation with quantitative analysisChest rising during basic life support will be recorded and evaluated (breath by breath) in QCPR Skill Reporter software | Procedure or surgery | Resusci Anne QCPR AED (Laerdal), Resusci Baby QCPR (Laerdal) |
Primary outcome
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
8 secondary outcomes
Volumetric analysis of mouth-to-mouth ventilation
Time frame: During 2 minute basic life support
Impact of training on incidence of effective mouth-to-mouth ventilation
Time frame: During 2 minute basic life support
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
Correct head position incidence
Time frame: During 2 minute basic life support
The incidence of ventilation without pinched nose
Time frame: During 2 minute basic life support
Mean breath volume
Time frame: During 2 minute basic life support
No-flow interval characteristics
Time frame: During 2 minute basic life support
Adverse events incidence
Time frame: During 2 minute basic life support
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Basic Life Support Ventilation
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
RecruitingObservational study
Evaluation of Foreign Body Airway Obstruction Interventions Among Young Children: A Prospective Cohort Study
Choking
RecruitingObservational study
Evaluation of Foreign Body Airway Obstruction Interventions: A Prospective Cohort Study of Adults and Children
Choking
Recruiting
Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?
Cardiac Arrest (CA)
RecruitingObservational study
The ICU LIBERATION Study
Acute Respiratory Distress Syndrome, Post Intensive Care Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Kosinova, assoc. prof. MD., Ph.D. principal investigator
Faculty of medicince Masaryk University and University Hospital Brno
Petr Stourac, prof.MD.Ph.D. study chair
Faculty of medicince Masaryk University and University Hospital Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basic Life Support Ventilation, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of effective mouth-to mouth ventilation (time frame: During 2 minute basic life support). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.