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NCT Number: NCT06410664

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

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

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Key information

Conditions

VAP - Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • Presence of HME-associated adverse events (a composite endpoint of endotracheal tube occlusion or nosocomial tracheobronchitis or pneumonia).
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

72-hour HME exchange interval group

Other

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.

24-hour HME exchange interval group

Other

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.

Primary outcomes

  1. Presence of HME-associated adverse events

    Time frame: 3 months

    A composite endpoint of nosocomial tracheobronchitis or pneumonia (all-cause, nosocomial and ventilator-associated) or endotracheal tube occlusion).

  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.

    Time frame: 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 outcomes

  1. Differences in the relative risk of infection-related ventilator-associated complications (IVAC) according to the Centers for Disease Control and Prevention (CDC) criteria.

    Time frame: 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 days

  2. ATB exposure analysis

    Time frame: 3 months

    Duration of antibiotics prescribed at discharge.

  3. Length of ICU stay in days

    Time frame: 3 months

    that is, length in ICU stay in days

  4. Number of ventilator-free days.

    Time frame: 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.

Other outcomes

  1. The length of ATB therapy until extubation, death or IVAC.

    Time frame: 3 months

    Cumulative percentage of days on the ventilator with ATB until extubation, death or IVAC.

  2. The values of HME performance in vivo (temperature) during mechanical ventilation.

    Time frame: up to 30 days

    The absolute temperature of input, load, return, loss, yield, and thermal differential, their variation over time (72 hours) and the differences between in vivo obtained values of HME performance indicators and their laboratory values declared by the manufacturer in the technical sheet and prescribed by the international standard.

  3. The values of HME performance in vivo (humidity) during mechanical ventilation.

    Time frame: up to 30 days

    The absolute humidity of input, load, return, loss, yield, and thermal differential, their variation over time (72 hours) and the differences between in vivo obtained values of HME performance indicators and their laboratory values declared by the manufacturer in the technical sheet and prescribed by the international standard.

  4. The change in resistance of the HME filter from day 0 to day 2 (72 hours) and during drug nebulisation

    Time frame: up to 30days

    The pressure drops over HME filter during mechanical ventilation.

  5. The change in resistance of the HME filter during drug nebulisation

    Time frame: up to 30 days

    The pressure drop over HME filter during drug nebulisation.

Study contacts

Contact information is provided by the study sponsor or research team.

Adéla Jiroudkova

CONTACT

[email protected]

+420 602 145 168

Šárka Línková

CONTACT

[email protected]

+420 723 638 719

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study 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

Acronym: FILTRex

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 13, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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