Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia

Not Applicable

Completed

• Conditions: Respiratory Failure

• Registration Number: NCT05403320
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-03
• Study Start: 2022-06-06
• Primary Completion: 2024-01-09
• Study Completion: 2024-04-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (11)

Shamir Medical Center; 🇮🇱 Tel Aviv, Israel

Azienda ospedaliera universitaria "Ospedali riuniti di Ancona"; 🇮🇹 Ancona, Italy

Azienda ospedaliera universitaria "Policlinico di Bari"; 🇮🇹 Bari, Italy

Humanitas Research Hospital; 🇮🇹 Milano, Italy

Azienda ospedaliera universitaria di Modena; 🇮🇹 Modena, Italy

Azienda ospedaliera Federico II; 🇮🇹 Napoli, Italy

Azienda ospedaliera universitaria "Luigi Vanvitelli"; 🇮🇹 Napoli, Italy

Policlinico "P. Giaccone"; 🇮🇹 Palerme, Italy

Azienda ospedaliera Perugia; 🇮🇹 Perugia, Italy

Fondazione Policlinico "A. GEMELLI"; 🇮🇹 Roma, Italy

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