Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia

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  • sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Updated on 27 June 2022
mechanical ventilation
carbon dioxide
assisted ventilation


Multicenter, cluster randomized, controlled, open-label trial to assess if AnapnoGuard System can minimize tracheal microaspiration and the risk of ventilator-associated pneumonia when compared to standard treatment


Maintaining the endotracheal tube (ETT) cuff appropriately inflated plays a crucial role in the management of intubated patients because overinflation may cause tracheal wall damage, ulcerations and stenosis, and underinflation may results in fluid leakage and ventilator-associated pneumonia (VAP).

During mechanical ventilation, secretions contaminated with oropharyngeal and gastric pathogens pool in the subglottic space (tracheal region between the ETT cuff and the vocal cords) and enter the lower airways via microaspiration.

Subglottic secretion drainage (SSD) reduces the incidence of VAP and can be performed intermittently or continuously, with varying efficacy and often causing secondary tracheal mucosa lesions.

AnapnoGuard (AG) ETT has three dedicated lines (two suction lines and one sensing/venting/rinsing line) and can be connected to the AG 100 System, a new device which provides high-sensitive capnography of subglottic space and consequent adjustment of cuff pressure, to avoid fluid leakage and overinflation. It also evacuates secretions from the subglottic space by simultaneously rinsing/venting this space using the ETT dedicated line.

The hypothesis is that AG System may reduce the incidence of microaspiration, bacterial tracheal colonization and consequently the risk of VAP when compared to standard treatment (ETT with manually performed secretion drainage and cuff pressure control).

Condition Respiratory Failure
Treatment Continuous cuff pressure regulation, Intermittent cuff pressure regulation, Automatic subglottic secretion drainage, Manual subglottic secretion drainage, Tracheobronchial colonization assessment, Microaspiration assessment, VAP assessment
Clinical Study IdentifierNCT05403320
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Last Modified on27 June 2022


Yes No Not Sure

Inclusion Criteria

Primary intubation with the study ETT
Expected duration of mechanical ventilation >48 hours
Age older than 18 years

Exclusion Criteria

Invasive mechanical ventilation in the last 14 days
Contraindication for enteral feeding
Clinical evidence of inhalation before intubation
Enrolling in another study that may interfere with this trial
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