Acute In Vivo Evaluation of the Pittsburgh Pediatric Ambulatory Lung

Area of Science:

• Biomedical Engineering
• Pediatric Respiratory Support
• Medical Device Development

Background:

• Respiratory failure is a critical concern in pediatric patients.
• Current respiratory support methods often limit patient mobility.
• Wearable devices like the Pittsburgh Pediatric Ambulatory Lung (P-PAL) offer potential for improved treatment and ambulation.

Purpose of the Study:

• To evaluate the acute (4-6 hours) in vivo performance of the P-PAL device.
• To establish an optimal implant strategy for future long-term studies of the P-PAL.
• To assess the safety and efficacy of the P-PAL in a relevant animal model.

Main Methods:

• The P-PAL was tested in healthy sheep (n=6) connected via cannulation of the right atrium and pulmonary artery.
• Measurements included plasma-free hemoglobin (PfHb), hemodynamics, and oxygen transfer rates at varying blood flows (1-2.5 L/min).
• An altered cannulation approach was developed to address flow limitation due to venous cannula occlusion.

Main Results:

• All sheep survived the acute study duration without device replacement.
• The P-PAL achieved 100% oxygen saturation in blood output, with minor exceptions due to priming issues.
• Plasma-free hemoglobin levels remained consistently low (<20 mg/dL), indicating minimal hemolysis.

Conclusions:

• The P-PAL demonstrated successful acute in vivo performance in a large animal model.
• The study established crucial methodologies for future long-term evaluations of wearable pediatric respiratory support.
• The P-PAL shows potential as a safe and effective device for ambulatory pediatric respiratory care.