225 - A novel, supraglottic, delivery device for instilling perfluorooctyl bromide for partial liquid ventilation in neonatal respiratory distress syndrome

Poster Number: 225
Publication Number: 225.2845

Background: Neonatal respiratory distress syndrome (RDS) remains a significant cause of morbidity and mortality in preterm infants. Despite advances in less invasive techniques for surfactant administration, some infants fail to respond to surfactant therapy. Perfluorooctyl bromide (PFOB), an inert fluorocarbon with anti-inflammatory, radiopaque and surfactant-like properties, has proven effective in intubated and mechanically ventilated, preterm, animal models and infants. The safety and efficacy of atomized PFOB in non-intubated spontaneously breathing animals or humans is unknown.

Objective: Develop a novel device capable of supraglottic delivery of PFOB for partial liquid ventilation (PLV) in spontaneously breathing neonates.

Design/Methods: The PFOB delivery device (PDV) is composed of an atomizing delivery catheter and camera attached to a positioning device. Engineering analysis determined the optimal dimensions of the device. Analysis of atomized plume formation optimized supraglottic positioning for maximal airway delivery of PFOB. In lambs, PDV was inserted into the oropharynx of sedated, spontaneously-breathing, preterm, neonatal lambs under direct video guidance and positioned above the glottic opening. Warmed PFOB was administered by syringe attached to the delivery catheter creating a plume that was aspirated into the larynx with inhalation. Distribution was determined by chest x-ray. For the human device, 7 neonatal care providers received a 20-minute instruction then attempted insertion on two neonatal intubation mannequins, a 24-week preterm and a term infant, using two PDV, one with the delivery tip at a 90^o and one at a 110^o angle to the long axis of the device.

Results: A straight device with a 90^o curve at the tip measuring 34.7 mm total length was created. The atomizing catheter and flexible endoscope camera position in longitudinal channels on the left and right sides of the device. The optimal oropharyngeal position was approximately 1 cm above the glottis. In lamb studies, the PDV delivered PFOB to 30 premature lambs with RDS with good lung distribution and no adverse effects. For the Pediatric device, each provider successfully positioned the devices in each mannequin. The device with the 90^o angle proved easiest to position. The glottis and supraglottic anatomy were well visualized. Atomizing PFOB produced larger droplets than aerosol and delivered the liquid within 3-5 minutes.

Conclusion(s): We developed a novel device for supraglottic delivery of PFOB for PLV in spontaneously breathing neonates. Studies are underway to further optimize the design for human use.