Efficacy of a 3D-Printed Personalized Artificial Airway Fixation Device in Obese Intensive Care Unit Patients: A Randomized Controlled Trial

Abstract Background Securing an artificial airway in obese patients is a significant clinical challenge due to anatomical factors, leading to high rates of tube displacement and pressure injuries. This study aimed to develop a personalized artificial airway fixation device using three-dimensional (3D) printing technology and to evaluate its clinical efficacy in this population. Methods In this single-center, two-arm randomized controlled trial, 66 obese patients (body mass index ≥ 28 kg/m²) requiring orotracheal intubation in an intensive care unit in China were randomly assigned (1:1) to a personalized 3D-printed fixation device designed from 3D facial surface scans (intervention group, n = 33) or a commercial fixation device (control group, n = 33). The primary outcome was endotracheal tube displacement (proportion with no displacement on a 5-level scale). Secondary outcomes were local skin irritation and airway management safety indicators (heart rate and pulse oxygen saturation [SpO 2 ] fluctuations and duration of irritative coughing during nursing procedures). Patients, nursing staff, and outcome assessors were not blinded; data analysts were blinded. Results All 66 patients were analyzed. The intervention group demonstrated significantly superior fixation efficacy, with 88% (29/33) of patients experiencing no displacement compared with 24% (8/33) in the control group (risk difference 63.6 percentage points, 95% confidence interval 41.0 to 77.2; P < 0.001); no unplanned extubation or other adverse events occurred. Local skin irritation was less frequent in the intervention group (3% vs. 24%; P = 0.027, Fisher's exact test). During nursing procedures, the intervention group showed significantly smaller fluctuations in heart rate ( β = -3.57) and SpO 2 ( β = -0.96), and shorter durations of irritative coughing ( β = -0.76) ( P < 0.001 for all). Conclusions Compared with a commercial device, the 3D-printed personalized artificial airway fixation device provided more stable tube fixation and reduced local skin irritation in obese intensive care unit patients, while improving procedural safety during nursing care. Larger multicenter trials with blinded outcome assessment are warranted. Trial registration: ClinicalTrials.gov, NCT07349433. Registered September 12, 2025. Retrospectively registered.