270
Participants
Start Date
June 6, 2022
Primary Completion Date
January 9, 2024
Study Completion Date
April 9, 2024
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)
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
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)
Manual subglottic secretion drainage
Subglottic secretions will be manually drained with a 10 mL syringe, using the only dedicated lumen
Tracheobronchial colonization assessment
Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture
Microaspiration assessment
Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase
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
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
"Fondazione Policlinico A. GEMELLI", Roma
Catholic University of the Sacred Heart
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER