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
Status: Recruiting
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
FILTRex is a single-centre, controlled, randomised, prospective, non-inferiority clinical trial to compare the efficiency and safety of prolonged (72-hours) versus standard (24-hours) duration of use for Heat and Moisture Exchange (HME) filters in adult mechanically ventilated critically ill patients
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years
• In-patient in ICU and expected to stay \> 3 days
• Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation ≥ 72h
• Clinical Pulmonary Infection score (CPIS) less than six at the baseline 5 No history and symptoms of aspiration at the baseline
Contact Information
Primary
Šárka Línková
sarka.franta@seznam.cz
+420 723 638 719
Backup
Adéla Jiroudkova
adela.jiroudkova@ruk.cuni.cz
+420 602 145 168
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 120
Treatments
Experimental: 72-hour HME exchange interval group
Intervention group: daily care will be provided according to the local standards, with an HME exchange interval every 72 hours
Active_comparator: 24-hour HME exchange interval group
Control group: daily care will be provided according to the local standards, with an HME exchange interval every 24 hours
Related Therapeutic Areas
Sponsors
Leads: Charles University, Czech Republic