NCT06410664

Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Rationale: Ventilator-associated pneumonia (VAP) is the most common hospital-acquired infection (HAI) in the intensive care unit (ICU), and its impact is very high in terms of morbidity, length of hospital stay and overall costs. Minimising manipulation and disconnection of the ventilator circuit by reducing the frequency of HME filter exchange may lower the risk of its secondary contamination, hence the incidence of VAP, while maintaining its efficacy in terms of sufficient humidification of the inhaled gas mixture and safety in terms of no or minimal change in resistance to airflow. Aim: To test the effectiveness and safety of prolonged (72-hour exchange interval) use of a single HME. Design: Prospective, single-centre, parallel-group randomised controlled trial. Subjects: ICU patients (general ICU) Treatment in the intervention group: HME filter exchange every 72 hours Control group: Standard-of-care: daily HME filter exchange Primary outcome: 1. Presence of HME-associated adverse events (a composite endpoint of endotracheal tube occlusion or nosocomial tracheobronchitis or pneumonia). 2. The cumulative incidence of lower respiratory tract microbial colonisation analysed by the Kaplan-Maier method, censored in the case of ICU discharge or extubation \> 24h. Secondary and exploratory outcomes: Differences in the relative risk of infection-related ventilator-associated complications, antibiotics (ATB) exposure analysis, length of ICU stay in days (time frame: three months), number of ventilator-free days (time frame: 28 days); differences in the incidence of endotracheal tube occlusion necessitating reintubation between individual groups, differences in airway resistance, humidity delivered to the patients and efficacy of HMEs between groups

Conditions

• VAP - Ventilator Associated Pneumonia

Interventions

Type	Name	Description
OTHER	72-hour HME exchange interval group	All patients in the experimental arm will receive the usual best medical and nursing care with respect to VAP prevention. A dual-limb ventilator circuit with a closed suction system will be used. Bronchodilation or inhalational antibiotics, when ordered, will be delivered by a meshed nebuliser, a part of the ventilatory support circuit and will not be removed between treatments. A closed-circuit suction device will be used, and the frequency of suctioning will be monitored, including the sputum consistency and blood on suctioning. HME filter resistance by estimating the pressure drop over HME using the ventilatory circuit's auxiliary force (Paux) and flow. Temperature and humidity in the ventilator circuit will be measured. HME filters will be exchanged every 72 hours. At the exchange point, both outlets of the HME filter will be swabbed.
OTHER	24-hour HME exchange interval group	All patients in the control arm will receive the usual best medical and nursing care with respect to VAP prevention. A dual-limb ventilator circuit with a closed suction system will be used. Bronchodilation or inhalational antibiotics, when ordered, will be delivered by a meshed nebuliser, a part of the ventilatory support circuit and will not be removed between treatments. A closed-circuit suction device will be used, and the frequency of suctioning will be monitored, including the sputum consistency and blood on suctioning. HME filter resistance by estimating the pressure drop over HME using the ventilatory circuit's auxiliary force (Paux) and flow. Temperature and humidity in the ventilator circuit will be measured. HME filters will be exchanged every 24 hours. At the exchange point, both outlets of the HME filter will be swabbed.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-08-01
• Completion: 2026-06-01
• First posted: 2024-05-13
• Last updated: 2024-07-26

Locations

1 site across 1 country: Czechia