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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help prevent a serious lung infection called ventilator-associated lower respiratory tract infections (VALRTI) in patients who are on mechanical ventilation for a longer period. The study will test whether managing the pressure of a special cuff (a device used to keep the airway open) and using a method to irrigate the airway can reduce the risk of these infections, especially in patients at high risk of swallowing problems.

To participate in this trial, you must be at least 18 years old and undergoing a procedure that requires intubation (inserting a tube into the airway) or tracheostomy (creating an opening in the neck for breathing support), with expected mechanical ventilation lasting over 72 hours. You also need to have certain risk factors, like having a history of swallowing difficulties or specific neurological conditions. The study is not yet recruiting participants, but if you or a loved one is eligible, you will receive detailed information and support throughout the trial, including the opportunity to give informed consent before joining. This means you can ask questions and fully understand what the study involves.

Gender

ALL

Eligibility criteria

• 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.