TRacheal Cuff PRessure Evaluation Study

Launched by POLICLINICO HOSPITAL · Feb 21, 2025

Keywords

ClinConnect Summary

The TRacheal Cuff PRessure Evaluation Study is a clinical trial designed to improve care for critically ill patients who are on mechanical ventilation, which is a machine that helps them breathe. This study is comparing two methods for managing the pressure in the cuff of an endotracheal tube (ETT), a tube that helps keep the airway open. One group of patients will use a continuous cuff pressure controller called TRACH FLUSH, while the other group will have nurses manually check and adjust the cuff pressure every eight hours. The goal is to see if the continuous controller can better maintain the correct pressure and reduce the risk of microaspiration, which can lead to pneumonia.

To be eligible for this study, patients must be receiving invasive mechanical ventilation for more than 24 hours and have a predicted need for it to last longer than 72 hours. Patients who have been intubated for more than six hours, are pregnant, or have had previous airway surgery cannot participate. Those who join the study will have their cuff pressure managed in one of the two ways mentioned and will be monitored for how well each method keeps the pressure in a safe range and reduces the presence of certain markers in their sputum, which may indicate aspiration events. This trial aims to improve patient safety and outcomes during mechanical ventilation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Required invasive mechanical ventilation expected to last for more than 24h
• • Signed informed consent
• Exclusion Criteria:
• • Intubated from more than 6 hours at the time of screening
• • Pregnancy
• • Previous surgery involving the airways