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NCT06848010: TRAC-PRES

TRacheal Cuff PRessure Evaluation Study

Not yet recruiting NA Last updated 28 January 2026
What this trial tests

NA trial testing Automated endotracheal cuff controller in Pneumonia, Ventilator-Associated in 54 participants. Not yet recruiting.

Timeline
15 February 2026
Primary endpoint
31 October 2026
31 December 2027

Quick facts

Lead sponsorPoliclinico Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment54
Start date15 February 2026
Primary completion31 October 2026
Estimated completion31 December 2027
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Policlinico Hospital

Who can join

18 and older, any sex, with Pneumonia, Ventilator-Associated or Mechanical Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Pneumonia, Ventilator-Associated

Currently open trials in the same condition.

Other Policlinico Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06848010.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing