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Combined Strategy Using Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring to Prevent Microaspiration: a Multicenter Randomized Controlled Trial.
Sponsor: University Hospital, Lille
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.
Official title: Combined Strategy to Prevent Microaspiration (CoSMic): Impact of the Combination of Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring on the Incidence of Abundant Microaspiration of Gastric or Oropharyngeal Secretions in Mechanically Ventilated Critically Ill Patents: a Multicenter Randomized Controlled Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2026-06-15
Completion Date
2028-07-15
Last Updated
2026-04-29
Healthy Volunteers
No
Interventions
Combined strategy
Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices
Automated subglottic secretion drainage
Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
Automated continuous cuff pressure monitoring
Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually
Control group
Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously