Abstract
INTRODUCTION: Procedural sedation during dental treatment has been reported to have a high incidence of respiratory depression. Nasal high flow (NHF) therapy uses a mild positive pressure load that improves carbon dioxide washout and reduces rebreathing to improve respiratory function and therefore is widely used to prevent hypoxemia and hypercapnia. We will investigate the efficacy of respiratory support with NHF during dental treatment under procedural sedation. METHODS/DESIGN: In a multicenter randomized controlled study, adult patients undergoing dental treatment under procedural sedation were allocated to either a nasal high-flow (NHF) group or a low-flow oxygen group. For sedation, midazolam plus propofol were used according to the guidelines to obtain a moderate sedation level. The primary endpoint is the incidence of hypoxemia, defined as SpO(2) ≤ 90% during intravenous anesthesia. As a secondary evaluation item, the percutaneous CO(2) concentration is evaluated to examine whether it is effective in preventing hypercapnia. Furthermore, we will evaluate sedative and analgesic doses, and examine whether the use of equipment is effective in preventing the occurrence of hypercapnia and hypoxemia. DISCUSSION: The purpose of this study was to obtain evidence for the utility of NHF as respiratory support for dental treatment under procedural sedation, assessed by determining if the incidence rates of hypercapnia and hypoxemia can be decreased by NHF. TRIAL STATUS: The protocol version number and date: Version 1.2 (approved on January 14, 2025). The date recruitment began: Patient recruitment began on August 1, 2025. The approximate date when recruitment will be completed: The patient recruitment will be completed on March 31, 2026.