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

NCT07555236 | Not Yet Recruiting

• 2 other identifiers: 2023_0735ID RCB
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ventilator-associated pneumonia incidence

  28 days

• Duration of mechanical ventilation

  28 days

• ICU length of stay

  28 days

• Mortality

  28 days

Study Arms (4)

Combined strategy

EXPERIMENTAL

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

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.

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.

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

Procedure: Control group

Interventions

Combined strategy PROCEDURE

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

Combined strategy

Automated subglottic secretion drainage PROCEDURE

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

Automated subglottic secretion drainage

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

Automated continuous cuff pressure monitoring

Control group PROCEDURE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Pneumonia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

DEMONT G IDE

CONTACT

00 33 3 20 44 44 95; gregoire.demont@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share