Clinical trial NCT06410664: Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: VAP - Ventilator Associated Pneumonia
Keywords: pneumonia
Heat and Moisture Exchange (HME) filter
VAP bundle in ICU
endotracheal tube occlusion
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be recruited in the medical-surgical ICU at Královské Vinohrady University Hospital (FNKV), managed under an intensivist-led closed ICU, with a 1:1 nurse-to-patient ratio and randomised in equal proportions between HME filter exchange every 72 hours versus daily HME filter exchange arm.
Primary purpose: PREVENTION

Brief 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

Eligibility 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

Primary outcomes:
measure: Presence of HME-associated adverse events
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: Differences in the relative risk of infection-related ventilator-associated complications (IVAC) according to the Centers for Disease Control and Prevention (CDC) criteria.
timeFrame: 3 months
measure: ATB exposure analysis
timeFrame: 3 months
measure: Length of ICU stay in days
timeFrame: 3 months
measure: Number of ventilator-free days.
timeFrame: at 28 days
Other outcomes:
measure: The length of ATB therapy until extubation, death or IVAC.
timeFrame: 3 months
measure: The values of HME performance in vivo (temperature) during mechanical ventilation.
timeFrame: up to 30 days
measure: The values of HME performance in vivo (humidity) during mechanical ventilation.
timeFrame: up to 30 days
measure: The change in resistance of the HME filter from day 0 to day 2 (72 hours) and during drug nebulisation
timeFrame: up to 30days
measure: The change in resistance of the HME filter during drug nebulisation
timeFrame: up to 30 days
Locations:
city: Prague
country: Czechia
facility: 3rd Faculty of Medicine and FNKV
state: Česká Republika
Study officials:
affiliation: 3rd Faculty of Medicine, Charles University and FNKV, Prague
name: Kateřina Jiroutková
role: PRINCIPAL_INVESTIGATOR
References: