Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia

Study Overview
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Brief Summary
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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
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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).

Official Title
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An Innovative Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia. A Multicenter Cluster-Randomized Trial

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: Continuous cuff pressure regulation
* Device: Intermittent cuff pressure regulation
* Device: Automatic subglottic secretion drainage
* Device: Manual subglottic secretion drainage
* Diagnostic Test: Tracheobronchial colonization assessment
* Diagnostic Test: Microaspiration assessment
* Diagnostic Test: VAP assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter cluster randomized controlled and open-label trial. Because intubation is an urgent intervention in critically ill patients patients with acute respiratory failure, individual randomization is considered too complex and we predetermined cluster of 9 consecutive patients, stratified by centers, with each cluster being assigned to one of the study groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AnapnoGuard group<br>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 | Device: Continuous cuff pressure regulation<br>* Within 24 hours, AnapnoGuard tube will be connected to AnapnoGuard 100 control device. It includes an automatic high-sensitive subglottic capnograph which measures every few minutes the carbon dioxide level in the subglottic space. If the level of carbon dioxide is above the threshold (established by animal studies) the system will increase the cuff pressure by a formula, if the level is below the threshold, the system will decrease the cuff pressure by 1 mmHg. Variations of cuff pressure are allowed only between pressure limits set by the user (minimum and maximum)<br>Device: Automatic subglottic secretion drainage<br>* Within 24 hours, AnapnoGuard tube will be connected to AnapnoGuard 100 device control which provides continuous subglottic secretion drainage (two different suction lines) and venting/rinsing (a third dedicated line)<br>Diagnostic Test: Tracheobronchial colonization assessment<br>* Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture<br>Diagnostic Test: Microaspiration assessment<br>* Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase<br>Diagnostic Test: VAP assessment<br>* Patients will be follow to detect clinical, radiological or microbiological signs of VAP. If suspected, a tracheal aspirate or a bronchoalveolar lavage is performed to confirm the diagnosis<br>|
| Active Comparator: Control group<br>Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning) | Device: Intermittent cuff pressure regulation<br>* ET cuff pressure will be manually measured three times per day using a portable manometer, and kept constant within 20-30 cmH2O<br>Device: Manual subglottic secretion drainage<br>* Subglottic secretions will be manually drained with a 10 mL syringe, using the only dedicated lumen<br>Diagnostic Test: Tracheobronchial colonization assessment<br>* Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture<br>Diagnostic Test: Microaspiration assessment<br>* Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase<br>Diagnostic Test: VAP assessment<br>* Patients will be follow to detect clinical, radiological or microbiological signs of VAP. If suspected, a tracheal aspirate or a bronchoalveolar lavage is performed to confirm the diagnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial tracheobronchial colonization (number of events) | The proportion of patients with bacterial tracheobronchial colonization (> 10^3 CFU/mL) on Day 3 after randomization, measured from tracheal aspirate | 3 days |