Performance of EasyBreath Decathlon Snorkeling mask for delivering continuous positive airway pressure

  1. Alberto Noto
  2. Claudia Crimi
  3. Andrea Cortegiani
  4. Massimiliano Giardina
  5. Filippo Benedetto
  6. Pietro Princi
  7. Annalisa Carlucci
  8. Lorenzo Appendini
  9. Cesare Gregoretti

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Abstract

During the COVID-19 pandemic, the need for noninvasive respiratory support devices has dramatically increased, sometimes exceeding hospital capacity. The full-face Decathlon snorkeling mask, EasyBreath (EB mask), has been adapted to deliver continuous positive airway pressure (CPAP) as an emergency respiratory interface. We aimed to assess the performance of this modified EB mask and to test its use during different gas mixture supplies. CPAP set at 5, 10, and 15 cmH 2 O was delivered to 10 healthy volunteers with a high-flow system generator set at 40, 80, and 120 L min −1 and with a turbine-driven ventilator during both spontaneous and loaded (resistor) breathing. Inspiratory CO 2 partial pressure (PiCO 2 ), pressure inside the mask, breathing pattern and electrical activity of the diaphragm (EAdi) were measured at all combinations of CPAP/flows delivered, with and without the resistor. Using the high-flow generator set at 40 L min −1 , the PiCO 2 significantly increased and the system was unable to maintain the target CPAP of 10 and 15 cmH 2 O and a stable pressure within the respiratory cycle; conversely, the turbine-driven ventilator did. EAdi significantly increased with flow rates of 40 and 80 L min −1 but not at 120 L min −1 and with the turbine-driven ventilator. EB mask can be safely used to deliver CPAP only under strict constraints, using either a high-flow generator at a flow rate greater than 80 L min −1 , or a high-performance turbine-driven ventilator.

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  1. Version published to 10.1038/s41598-021-85093-w
  2. ScreenIT

    SciScore for 10.1101/2020.10.28.20221317: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the Ethics committee of Policlinico G.
    Consent: All the study participants provided written informed consent.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Data analysis: A Matlab (version 9.7.0.1190202, The MathWorks Inc., Natick, Massachusetts, USA) automatic procedure was developed to find maximal and minimum EAdi (Figure 2) and pressure for each breath.
    Matlab
    suggested: (MATLAB, RRID:SCR_001622)
    The statistical analysis was performed using (SPSS 24, IBM) software.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    Results from OddPub: Thank you for sharing your data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Thus, in case of emergency use of the EB® mask, the first caveat is to use very high flows of fresh gas (about fourfold the peak inspiratory flow) in the circuit, whatever its source. Effectiveness in achieving target CPAP: An ideal CPAP system, by definition, should provide a target positive airway pressure through the respiratory cycle to improve alveolar recruitment and gas exchange. This was not the case of the EB® mask. Our data show that although the pressure inside the mask never dropped below zero during the inspiratory phase, it always remained far below the set CPAP level when using a fresh gas flow of 40 L min-1. On the other hand, during the expiratory phase, the pressure level recorded at the highest rate of fresh gas flow (120 L min-1) overcame the set CPAP level, at least at 5 and 10 cmH2O, potentially generating an undue increase in end-expiratory lung volume. Fresh gas flow of 80 L min-1 performed in the middle, overcoming the set pressure of 5 cmH2O and under-assisting at the target CPAP of 15 cmH2O. Mechanical ventilators are the most sophisticated devices to administer CPAP. However, old devices performed worse than high flow generators in delivering stable CPAP levels, mainly because of the demand-valve technology 18. The newer generation of ventilators has complex flow algorithms that allow for a more aggressive flow modulation and delivery flows using single circuits with intentional leaks designed to stabilize airway pressure and lessen the imposed wor...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

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  3. Version published to 10.1101/2020.10.28.20221317v1 on medRxiv