TRacheal Cuff PRessure Evaluation Study

Randomized clinical trial in mechanically ventilate critically ill patients. The study will evaluated the efficacy of a continous endotracheal tube (ETT) cuff pressure controller (TRACH FLUSH group) compared to manual monitoring and inflation (STANDARD group). Patients intubated, from at least 24 hours and with a predicted duration of invasive mechanical ventilation longer than 72 hours, will be randomized to the use of TRACH FLUSH versus nurse operated analogic cuff pressure controller q8. Hypotesis of the study is the superiority of the continuous cuff pressure controller in maintaining cuff pressure within the target value, thus decreasing the incidence of microaspiration events. Aim of the study are 1) to compare the incidence of cuff pressure value detection outside the target range between the TRACH FLUSH and the STANDARD group, and 2) to compare the incidence of sputum samples positive for (amylase and/or pepsin), a surrogate for tracheal micro-aspiration event.

NCT Number	NCT06848010
Lead Sponsor	Policlinico Hospital
Conditions	Pneumonia, Ventilator-Associated, Mechanical Ventilation
Enrollment	54 participants
Start Date	2026-02-15
Primary Completion	2026-10-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-28