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

Charles University, Czech Republic

Status: Enrolling

Conditions: VAP - Ventilator Associated Pneumonia

Treatments: Other: 24-hour HME exchange interval group; Other: 72-hour HME exchange interval group

Study type: Interventional

Funder types: Other

Identifiers

NCT06410664

VP/47/0/2022

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

72-hour HME exchange interval group

Experimental group

Description:

Intervention group: daily care will be provided according to the local standards, with an HME exchange interval every 72 hours

Treatment:

Other: 72-hour HME exchange interval group

24-hour HME exchange interval group

Active Comparator group

Description:

Control group: daily care will be provided according to the local standards, with an HME exchange interval every 24 hours

Treatment:

Other: 24-hour HME exchange interval group