Actively Recruiting
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
Led by Charles University, Czech Republic · Updated on 2024-07-26
120
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of using Heat and Moisture Exchange (HME) filters for either 72 hours or the standard 24 hours in adults who are critically ill and receiving mechanical ventilation in the intensive care unit (ICU). The study aims to see if prolonging the use of a single HME filter can reduce ventilator-associated pneumonia (VAP) by lowering the risk of secondary contamination while still providing proper humidification and airflow safety. This is a controlled, randomized clinical trial conducted at a single center. Participants are divided into two groups: one group receives HME filter changes every 72 hours, and the other group receives the standard daily filter changes every 24 hours. All patients receive standard medical and nursing care for preventing VAP, including the use of a dual-limb ventilator circuit with a closed suction system and delivery of inhaled treatments when needed. The study involves careful monitoring of suction frequency, sputum characteristics, filter resistance, temperature, and humidity in the ventilator circuit. At each filter change, swabs are taken from the filter outlets to analyze microbial colonization. During the study, participants will be closely monitored for the occurrence of HME-associated adverse events such as endotracheal tube blockage, tracheobronchitis, or pneumonia. Researchers will also track microbial colonization of the lower respiratory tract, infection-related ventilator complications, antibiotic use, length of ICU stay, and ventilator-free days. Measurements will be made over three months, with some outcomes assessed at 28 days. The trial includes double-blind randomization and aims to gather detailed safety and efficacy data to inform ICU care practices.
CONDITIONS
Brief Title
Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Currently admitted to an ICU and expected to stay more than 3 days
- Receiving mechanical ventilation or expected to require it for 72 hours or longer
- Clinical Pulmonary Infection Score (CPIS) less than six at baseline
- No history or symptoms of aspiration at baseline
You will not qualify if you...
- Suspected lung infection at admission or within the first 48 hours of mechanical ventilation
- Pregnancy
- Acute respiratory distress syndrome (ARDS)
- Body temperature below 32 degrees Celsius
- Airway bleeding or other reasons preventing use of an HME filter
- Early decision to withdraw treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive mechanical ventilation in ICU and are randomized to have their Heat and Moisture Exchanger (HME) filters exchanged either every 72 hours or every 24 hours as part of their ventilatory care.
Daily monitoring during ICU stay with HME filter exchanges every 24 or 72 hours depending on group assignment
Duration - Up to 3 months
Participants are monitored for the presence of HME-associated adverse events and lower respiratory tract microbial colonisation after treatment ends.
Regular assessments during ICU stay and at discharge or extubation
Trial Site Locations
Total: 1 location
1
3rd Faculty of Medicine and FNKV
Prague, Česká Republika, Czechia, 110 00
Actively Recruiting
Research Team
Š
Šárka Línková
A
Adéla Jiroudkova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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