Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU
- Conditions
- VAP - Ventilator Associated Pneumonia
- Interventions
- Other: 72-hour HME exchange interval groupOther: 24-hour HME exchange interval group
- Registration Number
- NCT06410664
- Lead Sponsor
- Charles University, Czech Republic
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- Suspected pulmonary infection on admission and in the first 48 hours of mechanical ventilation
- Pregnancy
- Acute respiratory distress syndrome
- Body temperature < 32°C
- Airway bleeding or other contraindications for the use of HME
- An early decision of treatment withdrawal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 72-hour HME exchange interval group 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 24-hour HME exchange interval group 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
- Primary Outcome Measures
Name Time Method Presence of HME-associated adverse events 3 months A composite endpoint of nosocomial tracheobronchitis or pneumonia (all-cause, nosocomial and ventilator-associated) or endotracheal tube occlusion).
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. 3 months To detect microorganisms in the lower respiratory tract, tracheal aspirate will be directly cultured for detecting Gram-positive, Gram-negative, and anaerobic bacteria and fungi. Standard microbial surveillance (tracheal aspirate) will be performed on admission, twice a week (Monday, Thursday) and always ad hoc according to the clinical situation.
- Secondary Outcome Measures
Name Time Method Differences in the relative risk of infection-related ventilator-associated complications (IVAC) according to the Centers for Disease Control and Prevention (CDC) criteria. 3 months Incidence rates among patients exposed to experimental intervention compared to those receiving standard care. We will establish the IVAC diagnosis based on the following:
* an increase of the daily minimum positive end-expiratory pressure (PEEP) of ≥3 cm of water column (H2O) and (or) the daily minimum inspired oxygen fraction (FiO2) of ≥20 points sustained for ≥2 days and
* evidence of a new infection present (abnormal temperature or white blood cell count) and prescription of a new antibiotic for ≥4 daysNumber of ventilator-free days. at 28 days That is, the number of days, out of 28 days after admission, that the patient has not been supported by mechanical ventilation.
ATB exposure analysis 3 months Duration of antibiotics prescribed at discharge.
Length of ICU stay in days 3 months that is, length in ICU stay in days
Trial Locations
- Locations (1)
3rd Faculty of Medicine and FNKV
🇨🇿Prague, Česká Republika, Czechia