Ventilation During ResuscitationMOVERESPNCT04867265
Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic
A study testing Mout-to-mouth ventilation and Mout-to-mouth ventilation with quantitative analysis in people with Ventilation During Resuscitation, run by Brno University Hospital at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilation During Resuscitation
- What is being tested?
- Mout-to-mouth ventilation and Mout-to-mouth ventilation with quantitative analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteCzechia
- Study dates
- 3 May 2021to 2 Jun 2021
- Phase
- Interventional
- 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
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.
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 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.
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 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
- 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
we will record the visibility of chest rising
Mout-to-mouth ventilation with quantitative analysisProcedure or surgery
Also called Mout-to-mouth ventilation
we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter
| Study group | Role | What they receive |
|---|---|---|
| Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan) | Active comparator | 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 Receives: Procedure: Mout-to-mouth ventilation |
| Resusci Anne QCPR AED (Laerdal) | Active comparator | 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 Receives: Procedure: Mout-to-mouth ventilation; Procedure: Mout-to-mouth ventilation with quantitative analysis |
| Resusci Baby QCPR (Laerdal) | Active comparator | 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 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.
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
Measured: During 2 minute basic life support
Secondary outcomes (8)
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
Measured: During 2 minute basic life support
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
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 posted30 Apr 2021
- Study start3 May 2021
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation During ResuscitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 104 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 Štourač, prof.MD.Ph.D., Study chair, Faculty of medicince Masaryk University and University Hospital Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867265
- Sponsor's protocol ID
- SIMU 1 2021
- Acronym
- MOVERESP
- Status last verified
- Jun 2021
- First submitted
- 26 Apr 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 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
- NCT04867265
- Acronym / sponsor ID
- MOVERESP / SIMU 1 2021
- Conditions
- Ventilation During Resuscitation
- Keywords
- Basic life support, COVID-19, Self-sterilizing nanofiber respirator, Mouth-to-mouth ventilation, Efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 3 May 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 30 Apr 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Professional Adult Medium Skin CPR-AED Training Manikin with CPR Monitor (Prestan) | Active comparator | Procedure: Mout-to-mouth ventilationmedical 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 |
| Resusci Anne QCPR AED (Laerdal) | Active comparator | Procedure: Mout-to-mouth ventilation, Procedure: Mout-to-mouth ventilation with quantitative analysismedical 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 |
| Resusci Baby QCPR (Laerdal) | Active comparator | Procedure: Mout-to-mouth ventilation, Procedure: Mout-to-mouth ventilation with quantitative analysismedical 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 ventilationwe will record the visibility of chest rising | 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: Mout-to-mouth ventilationwe will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter | Procedure or surgery | Resusci Anne QCPR AED (Laerdal), Resusci Baby QCPR (Laerdal) |
Primary outcome
Mouth-to-mouth ventilation effectivity
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
mouth-to-mouth ventilation volumetric analysis
Time frame: During 2 minute basic life support
medical students trained as BLS trainers versus medical students trained in BLS mouth-to-mouth breathing efficacy
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
Related trials for Ventilation During Resuscitation
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
Not yet recruiting
Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
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Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
Recruiting
Ventilation Performance and Feedback Simulation Trial
Out-of-hospital Cardiac Arrest (OHCA)
Recruiting
Supraglottic Airway for Resuscitation in Preemies
Respiratory Failure, Premature Neonates
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 Štourač, 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?
A study testing Mout-to-mouth ventilation and Mout-to-mouth ventilation with quantitative analysis in people with Ventilation During Resuscitation, 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: finished, as of the sponsor's last update on 3 Jun 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mouth-to-mouth ventilation effectivity (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 Jun 2021.