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

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07555236

Acronym

cosmic

Enrollment

800

Registered

2026-04-29

Start date

2026-06-15

Completion date

2028-07-15

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial

Keywords

Ventilator-associated pneumonia Prevention in intensive care units Subglottic secretion drainage

Brief 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.

Detailed description

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

Interventions

PROCEDURECombined strategy

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

PROCEDUREAutomated subglottic secretion drainage

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

PROCEDUREAutomated continuous cuff pressure monitoring

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

PROCEDUREControl group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

A prospective, multicenter, controlled, randomized, open-label study with four balanced parallel groups.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Frequency of global abundant microaspiration	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

Secondary

Measure	Time frame	Description
Ventilator-associated pneumonia incidence	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.
Duration of mechanical ventilation	28 days	Duration of mechanical ventilation during ICU stay, censored at day 28
ICU length of stay	28 days	ICU length of stay, censored at day 28
Mortality	28 days	Mortality censored at day 28

Contacts

CONTACTDEMONT G IDE

gregoire.demont@chru-lille.fr00 33 3 20 44 44 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026