Abstract:Objective To evaluate the effectiveness of a novel endoscopic oronasal shields in reducing aerosol transmission during upper gastrointestinal endoscopy. Methods Patients undergoing sedated upper gastrointestinal endoscopy at Lhasa People''s Hospital (December 2023-February 2024) were randomized 1∶1 via SAS 9.4 to shield or control groups. A six-channel particle counter (0.3, 0.5, 1.0, 2.5, 5.0, 10.0 µm) measured aerosol particles. The primary outcome was pre-/post-procedure aerosol variation at the endoscopist''s facial position. The secondary outcome was device safety. Results The study enrolled 100 patients (50 per group) with comparable baseline characteristics. Procedure duration showed no significant difference (7.8±3.9 min VS 8.1±4.2 min, t=0.500, P=0.615). The oronasal shield group demonstrated significantly reduced aerosol increases at 0.3 μm [(57.87±19.26)×10⁴/L VS (203.32±18.33)×10⁴/L, t=4.295, P<0.001], 0.5 μm [(19.36±3.60)×10⁴/L VS (64.61±12.67)×10⁴/L, t=4.949, P<0.001], 1.0 μm [(15.31±4.42)×10⁴/L VS (54.11±9.12)×10⁴/L, t=4.507, P<0.001], and 2.5 μm [(7.38±2.90)×10⁴/L VS (23.33±5.17)×10⁴/L, t=3.723, P<0.001]. Adverse event rates (cough, hiccups, hypoxemia, etc.) showed no significant differences (P>0.05). Conclusion Endoscopic oronasal shields safely reduce aerosol generation without prolonging procedure time, potentially mitigating exposure risks in endoscopy centers.