TRacheal Cuff PRessure Evaluation Study
Starting soon · Not applicable
Conditions studied: Pneumonia, Ventilator-Associated, Mechanical Ventilation
In brief
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.
Key facts
- Study ID
- NCT06848010
- Run by
- Policlinico Hospital
- People needed
- 54
- Starts
- 2026-02-15
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-01-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Required invasive mechanical ventilation expected to last for more than 24h
- Signed informed consent
You may not qualify if…
- Intubated from more than 6 hours at the time of screening
- Pregnancy
- Previous surgery involving the airways
Where it is running
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Milan, Italy
Full record on ClinicalTrials.gov
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