Clinical Trial

Combined Strategy Using Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring to Prevent Microaspiration: a Multicenter Randomized Controlled Trial.

Study acronym: cosmic
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Summary
This trial will study the impact of a combined strategy to prevent microaspiration of oropharyngeal secretions or gastric content using automated subglottic secretion drainage and/or continuous cuff pressure monitoring. These measures aim at preventing secretions of oropharyngeal or gastric origin from entering lower respiratory tracts of patients under invasive mechanical ventilation in intensive care units (ICU), referred to as microaspiration, in the hope of preventing ventilator-associated pneumonia, a condition associated with patient outcome worsening. Patients will be randomly assigned to one of four groups: a combined strategy group using both automated techniques, 2 groups using either one or the other automated technique, and a control group using standard of care. Microaspiration will be detected by measuring concentration of oropharyngeal (amylase) or gastric (pepsin) enzymes in tracheal aspirates.
Trial Details
NCT Number NCT07555236
Lead Sponsor University Hospital, Lille
Conditions Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial
Enrollment 800 participants
Start Date 2026-06-15
Primary Completion 2028-06-15 (estimated)
Study Completion 2028-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-29