Oxygen supplementation in pediatric sedation-prospective, multicenter, randomized controlled trial.

BACKGROUND Children undergoing moderate to deep sedation for diagnostic and therapeutic procedures are susceptible to hypoxemia because of their anatomical and physiological features. However, optimal oxygen administration methods are unclear. This study aimed to evaluate the efficacy of oxygen supplementation during sedation using either low-flow or high-flow nasal cannula (HFNC). METHODS This prospective, multicenter randomized controlled trial included children (<18 years) undergoing moderate to deep sedation. The participants were randomly assigned to three groups as follows: (1) control (no oxygen), (2) low-flow (LF) (2-6 L/min oxygen via nasal cannula), and (3) high-flow (HF) (oxygen administration via HFNC with a flow rate of 2 L/kg and 50% fraction of inspired oxygen). The primary outcome was hypoxemia incidence (saturation of peripheral oxygen, SpO2 ≤95% for more than 5 s). Secondary outcomes included SpO2 <90%, rescue interventions, and sedation-related complications. Between-group differences were compared using a logistic regression model. RESULTS A total of 253 participants were randomized, with 250 completing the study. Hypoxemia occurred in 27.6% of participants in the Control group, 7.2% in the LF group, and 1.2% in the HF group (p<0.001). The odds of hypoxemia in the LF and HF groups were lower than that in the Control group [odds ratio, OR=0.184 (95% CI, 0.067 - 0.503), p=0.001 for LF; OR=0.026 (95% CI, 0.003 - 0.207), p<0.001 for HF]. However, hypoxemia incidence of the HF group was not statistically lower than the LF group (OR 0.143 (95% CI, 0.017- 1.245), p=0.078). Rescue interventions were conducted more frequently in the Control group (52.9%) than in the LF (10.8%) and HF (3.6%) groups (p<0.001). Sedation-related complications such as desaturation and apnea were lower in the LF and HF groups than in the Control group (p<0.001). CONCLUSION Routine oxygen supplementation prevents hypoxemia during pediatric moderate and deep sedation. Low-flow oxygen can be a reasonable choice as it effectively reduces hypoxemia while being more cost-effective and widely accessible than high-flow oxygen.