The Effect of Continuous Management of Suction Cuff Pressure and Subglottic Irrigation Suction on Preventing VALRI Study

The Effect of Continuous Management of Suction Cuff Pressure and Subglottic Irrigation Suction on the Outcomes of Mechanically Ventilated Patients With High Risk of Aspiration: a Single-center, Prospective, Randomized Controlled Trial

Assessing the effectiveness of continuous cuff pressure management combined with subglottic suction irrigation in reducing ventilator-associated lower respiratory tract infections (VALRTI) in mechanically ventilated patients at high risk of aspiration.

Inclusion Criteria:

1. Age ≥ 18 years;
2. Undergoing endotracheal intubation or tracheostomy;
3. Expected duration of mechanical ventilation exceeding 72 hours;
4. Presence of one or more high-risk factors for reflux/aspiration: recurrent laryngeal nerve injury, cerebral infarction/cerebral hemorrhage (new or pre-existing swallowing dysfunction), cranial surgery/traumatic brain injury (TBI), neuromuscular junction disorders (e.g., myasthenia gravis, muscular dystrophy, Parkinson's disease, or other conditions that weaken swallowing muscle strength and coordination), continuous use of muscle relaxants for ≥ 48 hours during mechanical ventilation, ICU-acquired myopathy, ICU-acquired weakness, gastroparesis (gastric residual volume > 500 mL/6 hours), or impaired consciousness;
5. Voluntary participation in the study by the subject or their legal representative, with signed informed consent.

Exclusion Criteria:

1. Expected duration of mechanical ventilation less than 48 hours;
2. Pregnant or breastfeeding women;
3. Patients with tracheoesophageal or bronchopleural fistula;
4. Difficult intubation (more than three attempts) or patients with reflux/aspiration during intubation (with lung injury and secondary pulmonary infection);
5. Patients with irreversible disease, end-stage conditions, or those expected to die in the near future;
6. Patients already diagnosed with ventilator-associated pneumonia (VAP), i.e., excluding hospital-acquired pneumonia;
7. Patients participating in other clinical trials that are expected to influence the results of this study;
8. Patients deemed unsuitable for inclusion in the study by the investigator.