Personalized automatic management of tracheal cuff pressure and subglottic secretions drainage to prevent pneumonia in critically ill intubated patients. The MICROINHALO multicenter randomized controlled trial

Purpose: The MICROINHALO trial investigated whether personalized management of endotracheal tube cuff pressure (Pcuff) based on exhaled CO2 measurement combined with automatic subglottic space drainage (SSD) may prevent tracheal colonization in critically ill intubated patients. Methods: This cluster-randomized, international, open-label trial (NCT05403320) enrolled adult patients at 10 ICUs. They were randomly assigned to receive either an endotracheal tube equipped with automatic Pcuff management and SSD, or a conventional one with manual Pcuff management and manual SSD. The primary endpoint of the study was the rate of bacterial tracheal colonization (> 103 CFU/mL) on day 3 after intubation. Results: Among 270 randomized patients, 250 were included in the analysis: 127 allocated to the automatic management group and 123 to the manual management group. Bacterial tracheal colonization on day 3 occurred in 47 (37%) patients in the automatic management group and in 51 (41.5%) patients among controls (absolute difference - 4% [95% CI - 16 to 8], P = 0.52). The rate of clinically diagnosed (12.6% vs. 24.4%, P = 0.016) and microbiologically confirmed ventilator-associated pneumonia (VAP) (10.2% vs. 19.5%, P = 0.039) was significantly lower in the automatic management group, along with a lower percentage of Pcuff values outside the safety range (10.2% vs. 24.4%, P < 0.001) and a higher daily SSD volume (25 [8-41] mL vs. 10.5 [6-17] mL, P < 0.001). Conclusions: Among critically ill intubated patients, personalized automatic management of tracheal cuff pressure and subglottic secretion drainage was not superior to manual management to prevent tracheal colonization. Further research is warranted to confirm the observed effect on VAP rate reduction.