Evaluating the Nosten Device to Control Endotracheal Tube Balloon Pressure for Preventing Ventilator-Acquired Pneumonia in ICU Patients on Mechanical Ventilation

What this Trial Is About

Researchers are evaluating whether the Nosten4 device can reduce the time an endotracheal tubes balloon is underinflated and remove excess pressure. This may lower the risk of ventilator-acquired pneumonia VAP and early tracheal injuries caused by intubation. The main goal is to compare the effectiveness of the Nosten4 device versus manual monitoring and inflation of the balloon in preventing VAP. This multicenter, randomized, controlled study includes two groups one using the Nosten4 device to control cuff pressure and one using manual monitoring and inflation. Patients intubated through the mouth and expected to need mechanical ventilation for over 48 hours are included. The study plans to enroll 500 patients, split evenly between the two groups, to detect a difference in VAP occurrence with statistical power. Participants will be monitored for up to three months after inclusion. Researchers will assess the incidence of VAP based on American Thoracic Society criteria, bacterial colonization of the trachea, periods of balloon pressure abnormalities, antibiotic use duration, and early injuries to the larynx and trachea. The study includes blinded evaluation of the primary outcome and tracks patients as long as they remain intubated during this period.

Simple Mechanical Device to Control Pressure in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia