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

NCT ID: NCT06867237

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Ventilation Acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Suction cuff pressure and suction intervention

Group Type: ACTIVE_COMPARATOR

Suction cuff pressure

Intervention Type: DEVICE

Use the device to do continuous management of suction cuff pressure and subglottic irrigation suction

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Suction cuff pressure

Use the device to do continuous management of suction cuff pressure and subglottic irrigation suction

Intervention Type: DEVICE

Other Intervention Names

airway management

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ming Zhong

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Yanni Zhang, dr.

Role: CONTACT

zhang.yanni@zs-hospital.sh.cn

13381819621

Other Identifiers

B2025-070

Identifier Type: -

Identifier Source: org_study_id