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Comparison of Efficacy of Pressure Controlled vs. Traditional Manual Mask Ventilation for Newborn Resuscitation – A Simulation-Based Pilot Randomized Control Trial

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Abstract

Objectives

To determine efficacy of non-invasive positive pressure face mask ventilation using a ventilator device (NIPPmV) for achieving early effective ventilation compared to that by self-inflating bag (SIB) or T- piece resuscitator (TPR).

Methods

The authors video recorded 33 trained resuscitators using NIPPmV (provided using ventilator device), SIB [a 500 ml silicone SIB without a positive end expiratory pressure (PEEP) valve] and a TPR. Using a continuous pressure recording system and a neonatal manikin, the authors evaluated the efficacy of the ventilation to achieve early effective ventilation during 30 s of ventilation. The primary outcome was time to achieve effective chest rise. Secondary outcomes were peak inspiratory pressure (PIP), ventilation rate and the need to perform ventilation corrective steps during positive pressure ventilation (PPV) among the devices.

Results

Total 99 videos were recorded. The time(s) taken to achieve the first chest rise was significantly lesser in NIPPmV group compared to SIB and TPR (3.0 ± 1.7 vs. 3.7 ± 1.9 vs. 7.5 ± 5.4, respectively, p <0.001). The mean PIP delivered by NIPPmV compared to SIB & TPR (19.8 ± 1.6 vs. 35.6 ± 7.4 vs. 17.8 ± 2.0 cm H20 respectively; p <0.001) was more accurate with preset PIP. Ventilation, in terms of breath rate, was observed to be controlled more accurately with NIPPmV compared to SIB & TPR (50 vs. 42 vs. 33 per min respectively; p <0.001).

Conclusions

The non-invasive positive pressure face mask ventilation using a ventilator (NIPPmV) resulted in achieving early, effective and consistent ventilation.

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Acknowledgements

The authors sincerely thank Dr. Niranjan Khambete from Department of Clinical Engineering, for his inputs during data collection and Dr. Rajan Joshi HOD Pediatrics, for his valuable inputs while preparing the manuscript. The authors also thank team PediSTARS, Dr Jennifer Arnold, Dr Jonathan Duff, INSPIRE scientific review committee and IPSSV for their valuable inputs during initial designing of the study. They also thank CAE Healthcare for providing CAE Luna baby simulator for the study purpose.

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Authors

Contributions

SK conceptualized and designed the study. She collected the data, wrote initial draft and gave final approval. VU collected the data, did literature search, revised the manuscript critically and gave final approval. AVM analysed and interpreted the data, revised the manuscript critically for important intellectual content and approved the final manuscript. APP collected the data, did literature search, revised the manuscript and approved the final manuscript.

Corresponding author

Correspondence to Shilpa Kalane.

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Dr Rajan Joshi, Head, Department of Pediatrics, Deenanath Mangeshkar Hospital, Pune

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Kalane, S., Upadhye, V., Mulay, A.V. et al. Comparison of Efficacy of Pressure Controlled vs. Traditional Manual Mask Ventilation for Newborn Resuscitation – A Simulation-Based Pilot Randomized Control Trial. Indian J Pediatr (2023). https://doi.org/10.1007/s12098-023-04938-6

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  • DOI: https://doi.org/10.1007/s12098-023-04938-6

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