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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial
• Intervention / Treatment: Procedure: Combined strategy; Procedure: Automated subglottic secretion drainage; Procedure: Automated continuous cuff pressure monitoring; Procedure: Control group

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DEMONT G IDE; Phone Number: 00 33 3 20 44 44 95; Email: gregoire.demont@chru-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adult patients (> 18 years-old) admitted to the ICU Mechanical ventilation duration expected to be > 48 h Intubated with a tracheal tube allowing subglottic secretion drainage

Exclusion Criteria:

Ongoing pregnancy Patients lacking health insurance Patients lacking legal capacity Moribund patients (expected to die in the first 24 h of ICU stay) Patients with specific oropharyngeal conditions (e.g. severe soft tissue infections of the neck, pharyngeal or laryngeal surgery, history of larynx or pharynx irratidation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined strategy; Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices	Procedure: Combined strategy; Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices
Experimental: Automated subglottic secretion drainage; Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.	Procedure: Automated subglottic secretion drainage; Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
Experimental: 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: Automated continuous cuff pressure monitoring; Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually
Active Comparator: Control group; Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously	Procedure: Control group; Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of global abundant microaspiration	Microaspiration of oropharyngeal secretions will be detected by measuring amylase concentration levels in tracheal aspirates Microaspiration of gastric content will be detected by measuring pepsin concentration levels in tracheal aspirates Global abundant microaspiration will be defined by a proportion of at least 30% of tracheal aspirates with significant amylase and/or pepsin concentrations	48 hours after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator-associated pneumonia incidence	The incidence of ventilator-associated pneumonia (VAP) will be assessed using the 2005 IDSA/ATS guidelines. VAP will be suspected when a new or progressing chest X-ray infiltrate is associated to at least 2 criteria among: fever > 38 °C or < 35 °C, leukocytosis > 12 G/L or leukopenia < 4 G/L, purulent tracheal secretions. VAP will be confirmed when these criteria are associated to microbiological confirmation, with at least 105 CFU/mL in endotracheal aspirates or broncho-alveolar lavage.	28 days
Duration of mechanical ventilation	Duration of mechanical ventilation during ICU stay, censored at day 28	28 days
ICU length of stay	ICU length of stay, censored at day 28	28 days
Mortality	Mortality censored at day 28	28 days

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ventilator-associated pneumonia Prevention in intensive care units Subglottic secretion drainage
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 2023_0735; ID RCB (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No