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Purpose <p>The MICROINHALO trial investigated whether personalized management of endotracheal tube cuff pressure (P<i>cuff</i>) based on exhaled CO<sub>2</sub> measurement combined with automatic subglottic space drainage (SSD) may prevent tracheal colonization in critically ill intubated patients.</p> Methods <p>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 P<i>cuff</i> management and SSD, or a conventional one with manual P<i>cuff</i> management and manual SSD. The primary endpoint of the study was the rate of bacterial tracheal colonization (&gt; 10<sup>3</sup>&#xa0;CFU/mL) on day 3 after intubation.</p> Results <p>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 −&#xa0;4% [95% CI −&#xa0;16 to 8], <i>P</i> = 0.52). The rate of clinically diagnosed (12.6% vs. 24.4%, <i>P</i> = 0.016) and microbiologically confirmed ventilator-associated pneumonia (VAP) (10.2% vs. 19.5%, <i>P</i> = 0.039) was significantly lower in the automatic management group, along with a lower percentage of P<i>cuff</i> values outside the safety range (10.2% vs. 24.4%, <i>P</i> &lt; 0.001) and a higher daily SSD volume (25 [8–41] mL vs. 10.5 [6–17] mL, <i>P</i> &lt; 0.001).</p> Conclusions <p>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.</p> Graphical abstract <p></p>

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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

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  • 发表日期：

    2026年6月2日

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  • Gennaro De Pascale,
  • Salvatore Lucio Cutuli,
  • Maria Vargas,
  • Andrea Cortegiani,
  • Lidia Dalfino,
  • Massimiliano Greco,
  • Silvia Baroni,
  • Clelia Esposito,
  • Domenico Luca Grieco,
  • Reudor Grinberg,
  • Gianmarco Lombardi,
  • Vincenzo Pota,
  • Gabriele Presti,
  • Monica Stufano,
  • Eloisa Sofia Tanzarella,
  • Antonio Corcione,
  • Caterina Pace,
  • Maurizio Sanguinetti,
  • Tiziana Bove,
  • Andrea Urbani,
  • Massimo Girardis,
  • Maurizio Cecconi,
  • Giuseppe Servillo,
  • Giorgio Conti,
  • Massimo Antonelli,
  • Emanuele Oscar Franchini,
  • Valentina Di Gravio,
  • Daniel Livanu,
  • Luca Montini,
  • Antonio Maria Dell’Anna,
  • Gabriele Pintaudi,
  • Simone Carelli,
  • Francesca Sarlo,
  • Annachiara Marra,
  • Carmine Iacovazzo,
  • Raffaele Merola,
  • Luigi Curci,
  • Marco Fiore,
  • Francesco Coppolino,
  • Moana Rossella Nespoli,
  • Marco Rispoli,
  • Nadia Fusilli,
  • Manuela Mainetti,
  • Alessandra Magistrelli,
  • Massimo Vanoni,
  • Mariachiara Ippolito,
  • Maria Lapi,
  • Giovanna Cannizzaro,
  • Antonino Giarratano,
  • Rachele Iannuzziello,
  • Angela Miccolis,
  • Barbara Tucci,
  • Sestilio De Letteriis,
  • Noa Shney-Dor,
  • Alaa Igbaria,
  • Lucia Serio,
  • Andrea Carsetti,
  • Abele Donati,
  • Giorgia Montrucchio,
  • Luca Brazzi

摘要

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.

Graphical abstract