Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia

NACompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

June 6, 2022

Primary Completion Date

January 9, 2024

Study Completion Date

April 9, 2024

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

Trial Locations (11)

Unknown

Shamir Medical Center, Tel Aviv

"Azienda ospedaliera universitaria Ospedali riuniti di Ancona", Ancona

"Azienda ospedaliera universitaria Policlinico di Bari", Bari

Humanitas Research Hospital, Milan

Azienda ospedaliera universitaria di Modena, Modena

Azienda ospedaliera Federico II, Napoli

"Azienda ospedaliera universitaria Luigi Vanvitelli", Napoli

"Policlinico P. Giaccone", Palermo

Azienda ospedaliera Perugia, Perugia

Azienda ospedaliera universitaria Città della Salute e della Scienza di Torino - presidio Molinette, Torino

00168

"Fondazione Policlinico A. GEMELLI", Roma

All Listed Sponsors
collaborator

Catholic University of the Sacred Heart

OTHER

lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER