Design and Development of Novel Airway Device for Transoral Respiratory Monitoring During Sedation.
OBJECTIVES To design and develop an oral device to deliver O2 and measure CO2 in patients under sedation. METHODS Using computer-aided design and 3D printing, a novel Orocannula was made from thermoplastic polyurethane (TPU). Flow testing was performed through oxygen cannula tubing with and without external compression of the device. Clinical testing among patients undergoing surgery under sedation was performed. Intraoperative O2 and CO2 values were measured along with the need for device readjustment. RESULTS A minimally viable prototype was developed for preclinical testing. Compared to baseline flow rates, gas flow through oxygen cannula tubing was occluded by a 3 kg mass (mean flow: 0.04 L/min, SD ± 0.08, p < 0.01). Average flow rate through tubing inserted into the device did not differ from baseline flow (3.57 L/min, SD ± 0.46, p = 0.43), and the same 3 kg external mass did not occlude flow (3.66 L/min, SD ± 0.58, p = 0.52). Twenty patients were enrolled in the clinical study with a mean age of 65.8 years (SD ± 9.8, range: 49-83), and 60% were female. All patients successfully completed the trial with a mean operative duration of 52.7 min. Mean oxygen desaturation nadir was 94.8% (SD ± 2.9). The device remained in place without any dislodgement or adjustments in 75% of surgeries. CONCLUSIONS A transoral device for respiratory support and monitoring during sedation was produced with 3D printing and is compatible with existing nasal cannula tubing. The Orocannula demonstrated a high retention rate with preserved oxygenation, suggesting its potential as a viable clinical device. LEVEL OF EVIDENCE: 4