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NCT06848010: TRAC-PRES
TRacheal Cuff PRessure Evaluation Study
NA trial testing Automated endotracheal cuff controller in Pneumonia, Ventilator-Associated in 54 participants. Not yet recruiting.
31 October 2026
Quick facts
| Lead sponsor | Policlinico Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 54 |
| Start date | 15 February 2026 |
| Primary completion | 31 October 2026 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Automated endotracheal cuff controller
Conditions studied
- Pneumonia, Ventilator-Associated — all drugs for Pneumonia, Ventilator-Associated →
- Mechanical Ventilation — all drugs for Mechanical Ventilation →
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.
Verify or expand the search:
- PubMed search for NCT06848010
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pneumonia, Ventilator-Associated
Currently open trials in the same condition.
- NCT06467864 — Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological · recruiting
- NCT07052604 — Antibiotic Treatment for Pneumonia Caused by Stenotrophomonas Maltophilia in ICU Patients · recruiting
- NCT05843786 — Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients · Phase 3 · recruiting
- NCT05117125 — Biomarkers for Ventilator-associated Pneumonia · recruiting
Other Policlinico Hospital trials
Trials by the same sponsor.
- NCT06583642 — Antimicrobial Therapeutic Drug Monitoring During Lung Transplant Perioperative Phase · not yet recruiting
- NCT06302192 — Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study) · not yet recruiting
- NCT06312488 — Point of Care Evaluation of Fibrinolysis in Sepsis · NA · completed
- NCT06395259 — Observational Study on the Variation of Ascorbic Acid in Patients Undergoing Solid Organ Transplantation · active not recruiting
- NCT05691205 — Identifying Optimal PEEP After Lung Transplantation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06848010 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Policlinico Hospital
- Last refreshed: 28 January 2026
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