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

NCT06867237 | Not Yet Recruiting DMC

• 1 other identifier: B2025-070
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The number of days free from VALRTI within 28 days.

  The number of days free from ventilator-associated lower respiratory tract infection (VALRTI) within 28 days.

  28 days

Study Arms (2)

Suction cuff pressure and suction intervention

ACTIVE COMPARATOR

Device: Suction cuff pressure

Standard care

NO INTERVENTION

Interventions

Suction cuff pressure DEVICE

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

Also known as: airway management

Suction cuff pressure and suction intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Interventions

Airway Management

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yanni Zhang, dr.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03