Comparison of NaPSflex and standard nasal cannula during sedation for gastrointestinal endoscopy: a randomized controlled trial

The aim of this study was to compare the effectiveness and safety of a novel Nasal Pharyngeal Set-flexible (NaPS flex ) with the standard nasal cannula in maintaining oxygenation during painless gastrointestinal endoscopy. In this prospective, randomized trial, 376 patients undergoing sedated gastrointestinal endoscopy were assigned to oxygen delivery via standard nasal cannula or NaPS flex . The primary outcome was hypoxemia incidence (SpO 2 ≤ 90%). Secondary outcomes included severe hypoxemia (SpO 2 ≤ 75% or SpO 2 ≤ 90% lasting ≥ 60 s), airway interventions, anesthesiologist satisfaction, and sedation-related adverse events. In a trial of 376 patients, compared with standard nasal cannula, the use of NaPS flex was associated with a significantly lower incidence of hypoxemia (5.7% vs. 18.4%; P < 0.001) and severe hypoxemia (0% vs. 2.2%; P = 0.044). Interventions for hypoxia were less frequent with NaPS flex , including increased oxygen flow (5.2% vs. 18.4%; P < 0.001), mandibular thrust (3.4% vs. 9.8%; P = 0.018), and mask ventilation (1.7% vs. 8.0%; P = 0.006). Anesthesiologist satisfaction was higher with NaPS flex (97.7% vs. 90.8%; P = 0.006). There were no significant between-group differences in the duration of hypoxemia, the frequency of the lowest oxygen saturation, or the overall incidence of other adverse events (coughing, belching). Compared with standard nasal cannula, the novel Nasal Pharyngeal Set-flexible (NaPS flex ) improved oxygenation during sedated gastroscopy while maintaining safety, suggesting potential clinical utility. This study was registered with the Chinese Clinical Trial Registry (ChiCTR2400086626, Principal investigator: Zui Zou, Date of registration: 2024-7-8).