Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia

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

Conditions

• Respiratory Failure

Interventions

DEVICE

Continuous cuff pressure regulation

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)

DEVICE

Intermittent cuff pressure regulation

ET cuff pressure will be manually measured three times per day using a portable manometer, and kept constant within 20-30 cmH2O

DEVICE

Automatic subglottic secretion drainage

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)

DEVICE

Manual subglottic secretion drainage

Subglottic secretions will be manually drained with a 10 mL syringe, using the only dedicated lumen

DIAGNOSTIC_TEST

Tracheobronchial colonization assessment

Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture

DIAGNOSTIC_TEST

Microaspiration assessment

Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase

DIAGNOSTIC_TEST

VAP assessment

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Principal Investigators

• Gennaro De Pascale, MD · Fondazione Policlinico A. Gemelli IRCCS

• Massimo Antonelli, MD · Fondazione Policlinico A. Gemelli IRCCS

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-06

Primary Completion

2024-01-09

Completion

2024-04-09

Countries

• Israel
• Italy

Study Locations