Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07555236

Combined Strategy Using Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring to Prevent Microaspiration: 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Combined strategy

Procedure

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

Automated subglottic secretion drainage

Procedure

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

Automated continuous cuff pressure monitoring

Procedure

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

Control Group

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Duration of mechanical ventilation

    Time frame: 28 days

    Duration of mechanical ventilation during ICU stay, censored at day 28

  3. ICU length of stay

    Time frame: 28 days

    ICU length of stay, censored at day 28

  4. Mortality

    Time frame: 28 days

    Mortality censored at day 28

Study contacts

Contact information is provided by the study sponsor or research team.

DEMONT G IDE

CONTACT

[email protected]

00 33 3 20 44 44 95

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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.

Acronym: cosmic

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.