Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

Respiratory Failure

Treatments

Diagnostic Test: VAP assessment

Device: Intermittent cuff pressure regulation

Device: Manual subglottic secretion drainage

Device: Automatic subglottic secretion drainage

Diagnostic Test: Microaspiration assessment

Diagnostic Test: Tracheobronchial colonization assessment

Device: Continuous cuff pressure regulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05403320

4739

Details and patient eligibility

About

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

Full description

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).

Enrollment

270 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Pregnancy
Enrolling in another study that may interfere with this trial

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

270 participants in 2 patient groups

AnapnoGuard group

Experimental group

Description:

Patients intubated with AnapnoGuard endotracheal tube (polyvinylchloride tube with ellipsoidal shape, thin wall polyurethane cuff with dual suction lines and an extra venting line) which is connected to AnapnoGuard 100 System

Treatment: