A novel in-line high frequency interrupter for use with bubble CPAP: A feasibility study in a premature lamb model

Area of Science:

• Neonatal Physiology
• Respiratory Support
• Medical Device Innovation

Background:

• In vitro studies showed high-frequency (HF) oscillation with a novel flow interrupter (HFI) improved CO2 washout in bubble continuous positive airway pressure (BCPAP) for premature lungs.
• This study aimed to assess the safety and efficacy of HFI with BCPAP in an animal model before human trials.

Purpose of the Study:

• To evaluate the safety and efficacy of a novel HFI device used with BCPAP in a preterm lamb model.
• To determine the impact of different HF oscillation frequencies on respiratory parameters.

Main Methods:

• Twelve fetal lambs (131-135 days gestation) were mechanically ventilated and weaned to BCPAP.
• Measurements included end-tidal CO2 (EtCO2), tidal volume (VT), blood gases, heart rate (HR), arterial pressure (Part), and ventilatory efficiency index (VEI).
• Data were collected at baseline and during four randomized 10-minute intervals with HFI at 8, 10, 12, or 15 Hz.

Main Results:

• EtCO2 significantly decreased across all tested HF frequencies (p < 0.001).
• Ventilatory efficiency index (VEI) increased significantly (p < 0.011), and respiratory rate decreased.
• No significant changes were observed in blood gases, SpO2, HR, Part, MAP, VT, MV, or other measured respiratory mechanics.

Conclusions:

• The novel HFI device is safe and effective when used with BCPAP in a preterm lamb model.
• HF oscillation applied via the HFI device enhances CO2 clearance and improves ventilation efficiency without adverse physiological effects.