Combined Strategy Using Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring to Prevent Microaspiration: a Multicenter Randomized Controlled Trial. (cosmic)
April 21, 2026 updated by: University Hospital, Lille
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: DEMONT G IDE
- Phone Number: 00 33 3 20 44 44 95
- Email: gregoire.demont@chru-lille.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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.
|
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.
|
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
|
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
Time Frame: 48 hours after inclusion
|
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
Time Frame: 28 days
|
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
Time Frame: 28 days
|
Duration of mechanical ventilation during ICU stay, censored at day 28
|
28 days
|
|
ICU length of stay
Time Frame: 28 days
|
ICU length of stay, censored at day 28
|
28 days
|
|
Mortality
Time Frame: 28 days
|
Mortality censored at day 28
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023_0735
- ID RCB (Other Identifier: 2026-A00246-45)
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
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