Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

TRacheal Cuff PRessure Evaluation Study

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.

Participants needed: 54
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Policlinico HospitalUpdated: Jan 28, 2026Locations: 1
Eligibility criteria

Required invasive mechanical ventilation expected to last for more than 24h [+1]

Intubated from more than 6 hours at the time of screening [+2]

Status: Recruiting

The Hering-Breuer Reflex in Bilateral Lung Transplant Patients

The goal of this clinical trial (non-pharmacologic, single-center) is to determine whether the Hering-Breuer inflation reflex is preserved-and how it is modulated by end-expiratory pressure-in adult intensive-care patients who have undergone bilateral lung transplantation. The study will enroll men and women ≥ 18 years admitted to the ICU during the early weaning phase and will include a comparison group of intubated ICU patients after major non-thoracic surgery. The main questions it aims to answer are: * Is the Hering-Breuer reflex (measured as the ratio THBR/TSPONT) absent or attenuated in double-lung-transplant recipients? * Does changing the level of positive end-expiratory pressure (PEEP 8 vs 12 cmH₂O) influence the reflex? Comparison group: Researchers will compare the transplant arm (post-bilateral lung transplantation) with the control arm (post-operative, non-thoracic surgery patients) to see whether loss or blunting of the reflex-and its response to PEEP-differs between the two cohorts. Participants will: * Have a nasogastric catheter with embedded electrodes positioned to record the electrical activity of the diaphragm (EAdi). * Be ventilated in pressure-support mode at two preset PEEP levels (8 cmH₂O and 12 cmH₂O) during the weaning phase. * Receive one standardized high-volume insufflation at \~30 cmH₂O in each PEEP condition to elicit the reflex, while EAdi, airway pressures, inspiratory/expiratory times, and tidal volumes are recorded for 10 minutes per level.

Participants needed: 22
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Policlinico HospitalUpdated: Dec 12, 2025Locations: 1
Eligibility criteria

Age >18 years; [+3]

Re-transplantation or single-lung transplantation; [+11]

Status: Not yet recruiting

Antimicrobial Therapeutic Drug Monitoring During Lung Transplant Perioperative Phase

Background: Post-LUTX pneumonia represents a leading cause of death along the first month after LUTX. Donor-derived transmission of pathogenic species occurs up to 25% of recipients receiving a graft with a positive BAL culture, despite in-vitro adequate antimicrobial prophylaxis. Hypothesis: LUTX recipients are either exposed to suboptimal antimicrobial doses or antimicrobial penetration into the lug parenchyma is altered either due to surgery (absence of bronchial anastomoses) or to the hyperinflammatory state. Methods: LUTX recipients admitted to the intensive care unit at the Fondazione IRCCS Ca' Granda Policlinico Hospital. According to the institutional perioperative prophylaxis protocol and the donor/recipient ecology the most frequent antimicrobial molecules administered will be: cefepime, vancomycin, and meropenem. Antimicrobial pharmacokinetics will be investigated at three timepoints. Plasma levels of the ongoing antimicrobial molecule will be assessed at ICU admission, on postoperative day 1 and on postoperative day 3. Bronchoalveolar lavage (BAL) samples for the measurement of BAL antimicrobial levels will be collected during the BAL performed for clinical indication on postoperative day 1 and on postoperative day 3. Absolute plasma and BAL antimicrobial levels will be assessed. The ratio of BAL to plasma dosage of antimicrobial will be assessed to evaluate antimicrobial penetration within the target tissue. Correlation between both plasma and BAL antimicrobial dosage and recipients' postoperative fluid balance, body weight, vasopressor requirement, renal function will be performed.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Policlinico HospitalUpdated: May 22, 2025Locations: 1
Eligibility criteria

Recipient of LUTX [+2]

Age < 18 years old [+4]

Status: Not yet recruiting

Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)

This is a multicenter international observational prospective cohort study. The main questions it aims to answer are: * PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset * SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation

Participants needed: 164
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Policlinico HospitalUpdated: Mar 8, 2024
Eligibility criteria

Age > 18 years [+4]

AKI prior to the onset of ARDS [+16]