An Innovative Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia. A Multicenter Cluster-Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 270
- Locations
- 11
- Primary Endpoint
- Bacterial tracheobronchial colonization (number of events)
Study Overview
Brief Summary
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
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AnapnoGuard group
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
Intervention: Continuous cuff pressure regulation (Device)
AnapnoGuard group
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
Intervention: Automatic subglottic secretion drainage (Device)
AnapnoGuard group
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
Intervention: Tracheobronchial colonization assessment (Diagnostic Test)
AnapnoGuard group
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
Intervention: Microaspiration assessment (Diagnostic Test)
AnapnoGuard group
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
Intervention: VAP assessment (Diagnostic Test)
Control group
Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning)
Intervention: Intermittent cuff pressure regulation (Device)
Control group
Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning)
Intervention: Manual subglottic secretion drainage (Device)
Control group
Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning)
Intervention: Tracheobronchial colonization assessment (Diagnostic Test)
Control group
Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning)
Intervention: Microaspiration assessment (Diagnostic Test)
Control group
Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning)
Intervention: VAP assessment (Diagnostic Test)
Outcomes
Primary Outcomes
Bacterial tracheobronchial colonization (number of events)
Time Frame: 3 days
The proportion of patients with bacterial tracheobronchial colonization (\> 10\^3 CFU/mL) on Day 3 after randomization, measured from tracheal aspirate
Secondary Outcomes
No secondary outcomes reported