Abstract
Maintaining adequate oxygenation during pediatric bronchoscopy is critical for patient safety and procedural success. This study evaluates a novel supraglottic oxygen delivery technique designed to improve intraoperative oxygenation via a less invasive, more efficient approach. In this single-center, prospective, randomized controlled trial, children undergoing elective bronchoscopy were randomly assigned to receive oxygen through a novel nasal cannula (NNO) or conventional face mask (CMO), using computer-generated allocation sequences with concealed envelopes. The primary outcome was intraoperative hypoxemia (SpO₂ < 90% for > 10 s). Secondary outcomes included minimum SpO₂, severe hypoxemia (SpO₂ < 80%), frequency of mask ventilation due to desaturation, operator satisfaction with airway access and visual field, and time to first hypoxemic episode. Safety was assessed by comparing adverse event rates. In the intention-to-treat analysis of 199 randomized children, the incidence of hypoxemia was significantly lower in the NNO group than in the CMO group (6.0% vs. 18.2%; RR = 0.33, 95% CI 0.14-0.80; p = 0.008). Per-protocol analysis yielded consistent results (5.1% vs. 20.5%; p = 0.001). After multivariable adjustment, NNO remained a significant independent protective factor against hypoxemia (aOR = 0.272, 95% CI 0.098-0.753; p = 0.012). Secondary outcomes also favored NNO: lowest recorded SpO₂ was higher (94.9% vs. 93.5%, p = 0.003), mask interventions were fewer (2 vs. 13, p = 0.005), and time to hypoxemia was significantly prolonged (aHR = 0.203, 95% CI 0.075-0.547; p = 0.002). CONCLUSION: In children with American Society of Anesthesiologists (ASA) physical status I-II undergoing flexible bronchoscopy, the novel nasal cannula was more effective than the conventional face mask in preventing hypoxemia and reducing procedural interruptions. TRIAL REGISTRATION: The Chinese Clinical Trial Registry (chiCTR.gov): No. ChiCTR2500113734, Retrospectively registered, Date of registration: December 2, 2025. WHAT IS KNOWN: • Maintaining adequate oxygenation is essential for ensuring patient safety and procedural success during pediatric flexible bronchoscopy. • Conventional face masks (CMO) are widely used for oxygen delivery; however, they may be insufficient in preventing intraoperative hypoxemia. WHAT IS NEW: • A novel nasal cannula (NNO) significantly reduces the incidence of hypoxemia (6.0% vs. 18.2%) compared to CMO in children undergoing flexible bronchoscopy. • The use of NNO is associated with higher minimum SpO₂ levels, a longer time to onset of first hypoxemic event, and fewer procedural interruptions due to rescue ventilation, thereby providing a less invasive and more effective oxygenation strategy.