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NOT YET RECRUITING
NCT06848010
NA

TRacheal Cuff PRessure Evaluation Study

Sponsor: Policlinico Hospital

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-02-15

Completion Date

2027-12-31

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DEVICE

Automated endotracheal cuff controller

The automated endotracheal tube cuff pressure controller will continously assess and maintain the endotracheal tube cuff pressure at pre-specifed pressure level of 25 cmH20.

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milan, Italy