Oxygen Supplementation in Pediatric Sedation: Prospective, Multicenter, Randomized Controlled Trial
Abstract
Background: Children undergoing moderate to deep sedation for diagnostic and therapeutic procedures are susceptible to hypoxemia because of their anatomical and physiologic 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. Methods: This prospective, multicenter randomized controlled trial included children (younger than 18 yr) undergoing moderate to deep sedation. The participants were randomly assigned to three groups as follows: (1) control (no oxygen), (2) low-flow (2 to 6 l/min oxygen via nasal cannula), and (3) high-flow (oxygen administration via high-flow nasal cannula with a flow rate of 2 l/kg and 50% fraction of inspired oxygen). The primary outcome was hypoxemia incidence (saturation of peripheral oxygen, oxygen saturation measured by pulse oximetry 95% or less for more than 5 s). Secondary outcomes included oxygen saturation measured by pulse oximetry less than 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 low-flow group, and 1.2% in the high-flow group (P < 0.001). The odds of hypoxemia in the low-flow and high-flow groups were lower than that in the control…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 253 participants or records.
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