Not Yet RecruitingNot Applicable

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

90 participantsStarted 2025-03-01

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years;
✓. Undergoing endotracheal intubation or tracheostomy;
✓. Expected duration of mechanical ventilation exceeding 72 hours;
✓. 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;
✓. Voluntary participation in the study by the subject or their legal representative, with signed informed consent.

Exclusion criteria

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

What they're measuring

The number of days free from VALRTI within 28 days.

Timeframe: 28 days

Trial details

NCT IDNCT06867237

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Yanni Zhang, dr.

13381819621 zhang.yanni@zs-hospital.sh.cn

View on ClinicalTrials.gov More Ventilation Acquired Pneumonia trials