Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, ArtificialcosmicNCT07555236
Combined Strategy Using Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring to Prevent Microaspiration: a Multicenter Randomized Controlled Trial.
A study testing Combined strategy, Automated subglottic secretion drainage and Automated continuous cuff pressure monitoring in people with Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial, run by University Hospital, Lille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial
- What is being tested?
- Combined strategy, Automated subglottic secretion drainage and Automated continuous cuff pressure monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read the detailed description
Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
- Being tested
- Combined strategy, Automated subglottic secretion drainage, Automated continuous cuff pressure monitoring, Control group
- Keywords
- Ventilator-associated pneumonia Prevention in intensive care units Subglottic secretion drainage
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined strategyProcedure or surgery
Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices
Automated subglottic secretion drainageProcedure or surgery
Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
Automated continuous cuff pressure monitoringProcedure or surgery
Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually
Control groupProcedure or surgery
Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously
| Study group | Role | What they receive |
|---|---|---|
| Combined strategy | Experimental | Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices Receives: Procedure: Combined strategy |
| Automated subglottic secretion drainage | Experimental | Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually. Receives: Procedure: Automated subglottic secretion drainage |
| Automated continuous cuff pressure monitoring | Experimental | Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually. Receives: Procedure: Automated continuous cuff pressure monitoring |
| Control group | Active comparator | Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours after inclusion
Secondary outcomes (4)
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.
Measured: 28 days
Duration of mechanical ventilation
Duration of mechanical ventilation during ICU stay, censored at day 28
Measured: 28 days
ICU length of stay
ICU length of stay, censored at day 28
Measured: 28 days
Mortality
Mortality censored at day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multicenter, controlled, randomized, open-label study with four balanced parallel groups.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555236
- Sponsor's protocol ID
- 2023_0735
- Other IDs
- ID RCB
- Acronym
- cosmic
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07555236
- Acronym / sponsor ID
- cosmic / 2023_0735
- Keywords
- Ventilator-associated pneumonia Prevention in intensive care units Subglottic secretion drainage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A prospective, multicenter, controlled, randomized, open-label study with four balanced parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Combined strategy | Experimental | Procedure: Combined strategySubglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices |
| Automated subglottic secretion drainage | Experimental | Procedure: Automated subglottic secretion drainageSubglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually. |
| Automated continuous cuff pressure monitoring | Experimental | Procedure: Automated continuous cuff pressure monitoringTracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually. |
| Control group | Active comparator | Procedure: Control groupBoth tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined strategySubglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices | Procedure or surgery | Combined strategy |
| Automated subglottic secretion drainageSubglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually. | Procedure or surgery | Automated subglottic secretion drainage |
| Automated continuous cuff pressure monitoringTracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually | Procedure or surgery | Automated continuous cuff pressure monitoring |
| Control groupBoth tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously | Procedure or surgery | Control group |
Primary outcome
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
4 secondary outcomes
Ventilator-associated pneumonia incidence
Time frame: 28 days
Duration of mechanical ventilation
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Combined strategy, Automated subglottic secretion drainage and Automated continuous cuff pressure monitoring in people with Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DEMONT G IDE (00 33 3 20 44 44 95, gregoire.demont@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of global abundant microaspiration (time frame: 48 hours after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.