Prolonged use of HME filters in ICU patients
Safety and Efficiency of the Prolonged (72-hour) Use of a Single Heat and Moisture Exchanger in Adult Mechanically Ventilated Critically Ill and Its Impact on the Lower Respiratory Tract Pathogenic Microbial Colonisation Rate (FILTRex Trial); a Single-centre, Randomised, Controlled Trial
This study is testing if using special filters for 72 hours instead of 24 hours can help prevent lung infections in ICU patients on ventilators while keeping them comfortable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague, Česká Republika) |
| Trial ID | NCT06410664 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficiency and safety of using Heat and Moisture Exchange (HME) filters for 72 hours compared to the standard 24-hour exchange in adult patients on mechanical ventilation in the ICU. The study aims to reduce the risk of ventilator-associated pneumonia (VAP) by minimizing the manipulation of the ventilator circuit while ensuring adequate humidification and airflow. It is a single-centre, controlled, randomised, prospective trial that will assess the incidence of HME-related adverse events and microbial colonization in the lungs. The outcomes will help determine if prolonged use of HME filters is a safe and effective strategy in critically ill patients.
Who should consider this trial
Good fit: Ideal candidates are adult ICU patients who are expected to be mechanically ventilated for more than 72 hours.
Not a fit: Patients with suspected pulmonary infections or those requiring immediate treatment withdrawal may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of ventilator-associated pneumonia and improve patient outcomes in the ICU.
How similar studies have performed: While there have been studies on HME filters, this specific approach of prolonged use is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years 2. In-patient in ICU and expected to stay \> 3 days 3. Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation ≥ 72h 4. Clinical Pulmonary Infection score (CPIS) less than six at the baseline 5 No history and symptoms of aspiration at the baseline Exclusion Criteria: 1. Suspected pulmonary infection on admission and in the first 48 hours of mechanical ventilation 2. Pregnancy 3. Acute respiratory distress syndrome 4. Body temperature \< 32°C 5. Airway bleeding or other contraindications for the use of HME 6. An early decision of treatment withdrawal
Where this trial is running
Prague, Česká Republika
- 3rd Faculty of Medicine and FNKV — Prague, Česká Republika, Czechia (Recruiting)
Study contacts
- Principal investigator: Kateřina Jiroutková — 3rd Faculty of Medicine, Charles University and FNKV, Prague
- Study coordinator: Šárka Línková
- Email: sarka.franta@seznam.cz
- Phone: +420 723 638 719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.