Automated Versus Manual Endotracheal Tube Cuff Pressure Control in Mechanically Ventilated Children: A Randomized Crossover Trial

Background Optimal endotracheal tube cuff pressure is key for airway sealing and minimizing microaspiration and tracheal injury in ventilated children. However, intermittent manual monitoring can allow significant pressure changes and be affected by measurement artifacts, potentially reducing airway protection. Aims This study evaluated whether automated cuff pressure control better maintains target pressure than manual monitoring in ventilated children, and assessed its effects on off‐target pressure and workload. Methods In this prospective, randomized crossover study, mechanically ventilated pediatric patients (1 month–18 years) expected to require ventilation for ≥ 48 h underwent two randomized 24‐h monitoring phases (manual and automated). During the manual phase, cuff pressure was continuously displayed via a closed system without repeated disconnection of the manometer and was intermittently adjusted by bedside nurses according to a predefined protocol. During the automated phase, cuff pressure was continuously regulated using an automated control system to maintain a target range of 15–25 cmH 2 O. The primary outcomes were the frequency and cumulative duration of off‐target cuff pressure exposure; secondary outcomes included nursing workload. Results Thirty‐two patients completed both phases (768 measurements). Low cuff pressure episodes (< 15 cmH 2 O) were more frequent during manual monitoring than automated monitoring (12.7% vs. 1.3%, p < 0.001), while high‐pressure episodes (> 25 cmH 2 O) occurred only during manual monitoring (2.6% vs. 0%, p < 0.001). Total time outside the target range was markedly reduced with automated monitoring (118 vs. 10 h, p < 0.001). Nursing workload was significantly lower in the automated phase (3.65 h vs. 0.08 h, p < 0.001). Conclusions Automated cuff pressure control more reliably maintains target pressure and minimizes clinically important deviations compared to manual management. These results support adopting continuous automated regulation as a preferred strategy to enhance airway safety and reduce workload in mechanically ventilated children. Trial Registration ClinicalTrials.gov (NCT06965400)