Animal and clinical trials on a prototype, pressure limited, time cycled Philippine ventilator (PhilVent)

ABSTRACT

OBJECTIVE:To test the efficacy and safety of PhilVent™, a pressure limited, time cycled, Philippine ventilator through animal and clinical studies. METHODS AND RESULTS: Animal study Term, newborn piglets (N=8) were intubated and alternately cycled to the PhilVent™ or to a pressure limited, time cycled, commercial ventilator (Sechrist) at peak inspiratory pressures of 10, 13 and 15 cm H20 and rates of 15, 20, 25 breaths per min and constant FiO2 (0.40) and positive end expiratory pressure (+4). Blood gases and adverse events (pneumothorax, sudden deterioration, death) were monitored. Results show no significant difference in blood gases on either machine at the various ventilator settings. No adverse events occurred. Clinical study Prospective, randomized, controlled trial of 90 preterm infants with respiratory distress, randomized either to PhilVent™ (N=45) or Sechrist (N=45). Ventilator settings were adjusted to achieve predetermined range of blood gases. Arterial blood gases and any adverse events e.g., pneumothorax, pulmonary hemorrhage were monitored. There were no clinically significant differences in the ventilator settings or blood gases of the infants on the PhilVent™ or Sechrist. No increase in adverse events were noted with the PhilVent™. CONCLUSION: In animal and clinical studies, the efficacy and safety of the PhilVent were comparable to the Sechrist. The PhilVent™ is an effective, alternative ventilator for the treatment of respiratory insufficiency in newborn infants.