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

Fudan University

Status: Not yet enrolling

Conditions: Ventilation Acquired Pneumonia

Treatments: Device: Suction cuff pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06867237

B2025-070

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Suction cuff pressure and suction intervention

Active Comparator group

Treatment:

Device: Suction cuff pressure

Standard care

No Intervention group