Aim To compare positive pressure ventilation efficacy of a novel foot operated resuscitator (FOR) during positive pressure ventilation with that of self-inflating bag and mask (SIBM) using a manikin model.
Method A comparative trial was conducted with 117 participants at a level III neonatal intensive care unit using Baby Anne (Laerdal Medical, Norway). Flow and pressure sensors were used to measure tidal volume propelled (Vp) and delivered (Vt). Each participant delivered 60 breaths, using each device targeting adequate chest-rise defined as that corresponding to a Vt of 15–21 mL. Vt, Peak Inspiratory Pressure (PIP), Leak Percentage (%), Inspiratory Time (Ti, millisecond) and other parameters were recorded using a PC (Dell, Windows V.10) on a custom application (LabView 2014 platform NI, USA). The proportion of breaths achieving target range Vt, other key ventilation parameters and their variability were compared between a generic CE approved bag and mask and a novel FOR ( Neo Breathe, Phoenix Medical Systems, India).
Result Using an SIBM, participants delivered a mean (SD) Vt of 17.52 (5.22) mL, achieving target range Vt in 46.99% of all breaths, with a mean (SD) face-mask leak per cent of 32.51% (22.25). Using the FOR, participants delivered a mean (SD) Vt of 18.31 (3.90), achieving target range Vt in 54.37% of all breaths and a mean (SD) face-mask leak per cent of 18.89% (14.45). Variability of Vt, PIP and leak per cent was significantly reduced with FOR.
Conclusion FOR significantly reduced face-mask leak, significantly increased the proportion of breaths achieving Vt within optimal range and could offer a novel alternative to a SIBM.
- neonatal resuscitation
- tidal volume
- mask leak
- bag and mask
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Contributors SMN conceived, designed and conducted the study, and is the guarantor for the overall content. BVS and VTP collected the data and contributed to the final manuscript preparation. AGP conducted the statistical analysis and contributed to the final manuscript preparation. AAA assisted in statistical interpretation and manuscript writing and contributed to the final manuscript preparation and submission.
Funding Testing equipment was loaned by Windmill Health for the study. Neo Breathe unit used for the study was purchased by our hospital.
Disclaimer No other funding in cash or kind was sought or used.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study was approved by Institutional Ethics Committee of HM Patel Center for Medical Care and Education on 18 February 2017 vide Letter number IEC/HMPCMCE/72/Faculty/3/72/17.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.
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