- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04867265
Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic (MOVERESP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brno, Czechia, 62500
- Faculty of Medicine, Masaryk University Brno
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- medical students trained in BLS as BLS trainers
- medical students trained in BLS
Exclusion Criteria:
- refusing to participate
- non-medical students
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
we will record the visibility of chest rising
|
Active Comparator: 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
|
we will record the visibility of chest rising
we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter
Other Names:
|
Active Comparator: 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
|
we will record the visibility of chest rising
we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
During 2 minute basic life support
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mouth-to-mouth ventilation volumetric analysis
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
|
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 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
|
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
|
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)
|
During 2 minute basic life support
|
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
|
During 2 minute basic life support
|
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
|
During 2 minute basic life support
|
Mean breath volume
Time Frame: During 2 minute basic life support
|
Mean breath volume during mouth-to-mouth ventilation will be recorded
|
During 2 minute basic life support
|
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
|
During 2 minute basic life support
|
Adverse events incidence
Time Frame: During 2 minute basic life support
|
Incidence of adverse events
|
During 2 minute basic life support
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Petr Stourac, prof.MD.Ph.D., Faculty of medicince Masaryk University and University Hospital Brno
- Principal Investigator: Martina Kosinova, assoc. prof. MD., Ph.D., Faculty of medicince Masaryk University and University Hospital Brno
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIMU 1 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventilation During Resuscitation
-
University of ThessalyUnknownVentilation During Cardiopulmonary ResuscitationGreece
-
The University of Texas Health Science Center,...Completed
-
Ain Shams UniversityCompletedMechanical Ventilation During AnesthesiaEgypt
-
University Health Network, TorontoCompletedOxygenation During One Lung VentilationCanada
-
Seoul National University Bundang HospitalUnknownArterial Oxygenation During Protective One Lung VentilationKorea, Republic of
-
Rush University Medical CenterCompletedAdvanced Cardiac Life Support, Cardiopulmonary Resuscitation, Tidal Volume, Manual VentilationUnited States
-
University of California, DavisCompletedEvaluate the Changes in Respiratory Heat Content During One Lung VentilationUnited States
-
University of ZurichCompletedPatients Undergoing Elective Thoracic Surgery Requiring Obligatory Single-lung Ventilation During SurgerySwitzerland
-
National Taiwan University HospitalUnknownThe Comparison of the I-gel and Endotracheal Tube About in Different Ventilation Settings During Laparoscopic SurgeryTaiwan
-
Assistance Publique Hopitaux De MarseilleCompletedAcute Circulatory Failure During One-lung Ventilation SurgeryFrance
Clinical Trials on Mout-to-mouth ventilation
-
Brno University HospitalMasaryk UniversityWithdrawnBasic Life Support VentilationCzechia
-
Tampere University HospitalTerminated
-
Massachusetts General HospitalCompletedCardiopulmonary Resuscitation | Respiratory PhysiologyUnited States
-
IRCCS San RaffaeleCompleted
-
Johannes Gutenberg University MainzCompletedVentilation Therapy; ComplicationsGermany
-
McMaster UniversityUnknown
-
Daping Hospital and the Research Institute of Surgery...Enrolling by invitation
-
Hospital Clinic of BarcelonaHospital Universitari Vall d'Hebron Research Institute; Fundació Institut de...CompletedChronic Respiratory Failure
-
Fondazione Don Carlo Gnocchi OnlusFondazione Salvatore MaugeriCompleted