Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia
- Conditions
- Respiratory Failure
- Interventions
- Device: Continuous cuff pressure regulationDevice: Intermittent cuff pressure regulationDevice: Automatic subglottic secretion drainageDevice: Manual subglottic secretion drainageDiagnostic Test: Tracheobronchial colonization assessmentDiagnostic Test: Microaspiration assessmentDiagnostic Test: VAP assessment
- Registration Number
- NCT05403320
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- Primary intubation with the study ETT
- Expected duration of mechanical ventilation >48 hours
- Age older than 18 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AnapnoGuard group Continuous cuff pressure regulation 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 AnapnoGuard group Tracheobronchial colonization assessment 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 Control group Intermittent cuff pressure regulation Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning) AnapnoGuard group Automatic subglottic secretion drainage 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 AnapnoGuard group Microaspiration assessment 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 Control group Manual subglottic secretion drainage Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning) Control group VAP assessment Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning) AnapnoGuard group VAP assessment 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 Control group Tracheobronchial colonization assessment Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning) Control group Microaspiration assessment Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning)
- Primary Outcome Measures
Name Time Method Bacterial tracheobronchial colonization (number of events) 3 days The proportion of patients with bacterial tracheobronchial colonization (\> 10\^3 CFU/mL) on Day 3 after randomization, measured from tracheal aspirate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Shamir Medical Center
🇮🇱Tel Aviv, Israel
Azienda ospedaliera universitaria "Policlinico di Bari"
🇮🇹Bari, Italy
Azienda ospedaliera universitaria "Ospedali riuniti di Ancona"
🇮🇹Ancona, Italy
Humanitas Research Hospital
🇮🇹Milano, Italy
Azienda ospedaliera Federico II
🇮🇹Napoli, Italy
Azienda ospedaliera universitaria di Modena
🇮🇹Modena, Italy
Fondazione Policlinico "A. GEMELLI"
🇮🇹Roma, Italy
Azienda ospedaliera universitaria "Luigi Vanvitelli"
🇮🇹Napoli, Italy
Policlinico "P. Giaccone"
🇮🇹Palerme, Italy
Azienda ospedaliera Perugia
🇮🇹Perugia, Italy
Azienda ospedaliera universitaria Città della Salute e della Scienza di Torino - presidio Molinette
🇮🇹Torino, Italy