Born not breathing: A randomised trial comparing two self-inflating bag-masks during newborn resuscitation in Tanzania

Neonatal mannequin comparison of the Upright self-inflating bag and snap-fit mask versus standard resuscitators and masks: leak, applied load and tidal volumes

“…It is possible that the higher PIP and tidal volume seen with the Upright SIB are related to the 33% larger volume of the bag compared with the standard SIB, permitting resuscitators to squeeze in more gas with each inflation. In the recent clinical trial,9 PIPs and tidal volumes were also higher with the Upright/snap-fit combination, and were higher than those reported in our study (PIP 31–34 cmH 2 O vs 28–31 cmH 2 O in our study, and tidal volumes 8–10 mL/kg vs 5–7 mL/kg for a hypothetical birth weight of 3–3.5 kg in our study). In the clinical trial, no differences in clinical outcomes were seen beyond 30 min of life.…”

“…The only clinical trial using the Upright device published to date compared the two combinations of Upright/snap-fit with standard equipment in a resource-limited setting 9. In that study, leak was similar between groups (46.9% with Upright/snap-fit and 47.5% with standard equipment) but the Upright/snap-fit combination resulted in higher tidal volumes and peak pressures.…”

“…Both mannequin studies,7 8 and the clinical trial,9 reported that participants preferred the Upright/snap-fit combination; reasons included providing a better mask seal and easier visualisation of chest rise during ventilation. Similarly, the majority of participants in our study favoured the snap-fit mask, and the Upright SIB over the standard SIB, though the Neopuff TPR was the device of choice.…”

Non-clinical performance and acceptability of a small portable respiratory stimulator device for basic neonatal resuscitation

“…We have not found studies evaluating prototypes similar to ours. However, in 2017, the results of the evaluation of the performance and acceptability of a self-inflating neonatal bag for vertical use were published compared to the conventional design for use in the standard transverse position (33)(34)(35) . The first study assessed the performance of the devices analysing videos of participants ventilating a manikin using an upright device compared to the standard device (33) .…”

“…The second trial found that the vertical device offered higher volumes and lower mask leakage compared to the standard in a manikin model (34) . The third study developed a trial in Tanzania to compare both devices, and it founds relevant results favouring the upright device (35) . An appropriate sequence for efficacy and safety assessment in medical devices requires to progress from the evaluation in the laboratory to the evaluation in manikins and humans described, as described in this section.…”