Comparison of positive pressure ventilation devices during compliance changes in a neonatal ovine model

BACKGROUND

To compare tidal volume (VT) delivery with compliance at 0.5 and 1.5 mL/cmH2O using four different ventilation (PPV) devices (i.e., self-inflating bag (SIB), T-Piece resuscitator, Next Step (a novel Neonatal Resuscitator), and Fabian ventilator (conventional neonatal ventilator) using a neonatal piglet model.

DESIGN/METHODS

Randomized experimental animal study using 10 mixed-breed neonatal piglets (1–3 days; 1.8–2.4 kg). Piglets were anesthetized, intubated, instrumented, and randomized to receive positive pressure ventilation (PPV) for one minute with a SIB with or without a respiratory function monitor (RFM), T-Piece resuscitator with or without an RFM, Next Step, and Fabian Ventilator with both compliance levels. Compliance changes were achieved by placing a wrap around the piglets’ chest and tightened it. Our primary outcome was targeted VT delivery of 5 mL/kg at 0.5 and 1.5 mL/cmH2O lung compliance.

RESULTS

At 0.5 mL/cmH2O compliance, the mean(SD) expired VT with the Next Step was 5.1(0.2) mL/kg compared to the Fabian 4.8(0.5) mL/kg, SIB 8.9(3.6) mL/kg, SIB + RFM 4.5(1.8) mL/kg, T-Piece 7.4(4.3) mL/kg, and T-Piece+RFM 6.4(3.1) mL/kg. At 1.5 mL/cmH2O compliance, the mean(SD) expired VT with the Next Step was 5.2(0.6) mL/kg compared to the Fabian 4.4(0.7) mL/kg, SIB 12.1(5.3) mL/kg, SIB + RFM 9.4(3.9) mL/kg, T-Piece 8.6(1.5) mL/kg, and T-Piece+RFM 6.5 (1.6) mL/kg.

CONCLUSION

The Next Step provides consistent VT during PPV, which is comparable to a mechanical ventilator.

Pediatric Research; https://doi.org/10.1038/s41390-024-03028-3

IMPACT:

● Current guidelines recommend fixed peak inflation pressure in resuscitation, linked to lung and brain injury.

● The Next Step Neonatal Resuscitator, a cost-effective device, offers volume-targeted positive pressure ventilation with consistent tidal volumes.

● With two different compliances, the Next Step Neonatal Resuscitator delivered a consistent tidal volume which was similar to a mechanical ventilator.

● The Next Step Neonatal Resuscitator outperformed self-inflating bags and T-Pieces in delivering targeted tidal volumes.

● The Next Step Neonatal Resuscitator could be an alternative ventilation device for neonatal resuscitation.

What is the Next Step Neonatal Resuscitator? check it out at https://kmmedical.co.nz

The NextStep™  has been developed, patented internationally and independently tested to address the unmet need for Volume-Controlled, safe Neonatal Resuscitation, throughout changes in lung compliance, as the New-born’s lungs transition to life outside the womb.

The NextStep™ is driven by a micro controller and highly accurate miniature linear servomotor, similar to those used in robotic surgery, providing control to within 10% of Operator pre-set target Volume, throughout changes in lung compliance.

The NextStep™ is automated, easy-to-use with continuously monitored Operator SafeSet™ functions ensuring VoluSafe™ operation

• Volume (Vt)

• Pressure (Pmax)

• Respiratory Rate (RR)

• Inspiratory / Expiratory Ratio (I:E)

• Flow Rate

• PEEP

• Continuous Positive Airway Pressure (CPAP)