Comparison of the innovative endoscopic oropharyngeal airway and the conventional mouthpiece in elderly outpatients undergoing esophagogastroduodenoscopy under sedation: a prospective and randomized study

BACKGROUND: Undesirable outcomes may appear for elderly patients undergoing esophagogastroduodenoscopy (EGD) under sedation, such as hypoxia and hypotension. The aim of our study was to investigate the ability of the innovative endoscopic oropharyngeal airway to reduce the frequency of hypoxia during EGD under sedation in elderly patients. METHODS: In this trial, aged patients undergoing EGD were randomized into airway group and mouthpiece group. The primary outcome was the incidence of the minimum pulse oxygen saturation < 90% and minimum pulse oxygen saturation. In addition, sedation dose, recovery time, emergency management and adverse reactions were recorded. RESULTS: 360 patients completed the study (180 in each groups). The minimum pulse oxygen saturation during EGD was significantly higher in airway group (97.66 ± 2.96%) than in mouthpiece group (95.52 ± 3.84%, P < 0.001). The incidence of pulse oxygen saturation of 85–89% of airway group (5.0%, 9/180) was lower than mouthpiece group (10.6%, 19/180, P = 0.049). The endoscopy entry time in airway group was 3 (2, 4) seconds and in mouthpiece group was 5 (4, 6) (P < 0.001). Propofol total dose and awakening time were significantly lower in the airway group than in the mouthpiece group (P = 0.020 and P = 0.012, respectively). Furthermore, the incidence rate of hypotension was significantly higher in mouthpiece group (12.2%) than in airway group (5.0%) (P = 0.015). By comparison with the mouthpiece group, the satisfaction of endoscopists was higher in airway group (P = 0.012). CONCLUSION: Elderly patients undergoing EGD, Endoscopy Protector was associated with a significantly lower incidence of hypoxia, shortened endoscopy entry time and more stable hemodynamics. Trial registration: ChiCTR, ChiCTR2000031998, 17/04/2020. http://www.chictr.org.cn/index.aspx