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NOT YET RECRUITING
NCT07555236
NA

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

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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

PROCEDURE

Combined strategy

Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices

PROCEDURE

Automated subglottic secretion drainage

Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.

PROCEDURE

Automated continuous cuff pressure monitoring

Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually

PROCEDURE

Control group

Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously