VAP - Ventilator Associated PneumoniaFILTRexNCT06410664
Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU
A study testing 72-hour HME exchange interval group and 24-hour HME exchange interval group in people with VAP - Ventilator Associated Pneumonia, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia
- What is being tested?
- 72-hour HME exchange interval group and 24-hour HME exchange interval group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
3rd Faculty of Medicine and FNKV
Prague, Česká Republika, 110 00
Šárka Línková, +420 723 638 719, sarka.franta@seznam.cz
Kateřina Jiroutková, MD, +420 724 259 492, katka.nova@post.cz
About this study
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
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
Read the 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:
- 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
- Conditions
- VAP - Ventilator Associated Pneumonia
- Being tested
- 72-hour HME exchange interval group, 24-hour HME exchange interval group
- Keywords
- pneumonia, Heat and Moisture Exchange (HME) filter, VAP bundle in ICU, endotracheal tube occlusion
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
72-hour HME exchange interval groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 72-hour HME exchange interval group | Experimental | Intervention group: daily care will be provided according to the local standards, with an HME exchange interval every 72 hours Receives: Other: 72-hour HME exchange interval group |
| 24-hour HME exchange interval group | Active comparator | Control group: daily care will be provided according to the local standards, with an HME exchange interval every 24 hours Receives: Other: 24-hour HME exchange interval group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of HME-associated adverse events
A composite endpoint of nosocomial tracheobronchitis or pneumonia (all-cause, nosocomial and ventilator-associated) or endotracheal tube occlusion).
Measured: 3 months
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.
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.
Measured: 3 months
Secondary outcomes (4)
Differences in the relative risk of infection-related ventilator-associated complications (IVAC) according to the Centers for Disease Control and Prevention (CDC) criteria.
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
Measured: 3 months
ATB exposure analysis
Duration of antibiotics prescribed at discharge.
Measured: 3 months
Length of ICU stay in days
that is, length in ICU stay in days
Measured: 3 months
Number of ventilator-free days.
That is, the number of days, out of 28 days after admission, that the patient has not been supported by mechanical ventilation.
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 May 2024
- Primary completionAug 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kateřina Jiroutková, Charles University, Czech Republic
- Investigators
- Kateřina Jiroutková, Principal investigator, 3rd Faculty of Medicine, Charles University and FNKV, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410664
- Sponsor's protocol ID
- VP/47/0/2022
- Acronym
- FILTRex
- Status last verified
- Jul 2024
- First submitted
- 2 May 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06410664
- Acronym / sponsor ID
- FILTRex / VP/47/0/2022
- Conditions
- VAP - Ventilator Associated Pneumonia
- Keywords
- pneumonia, Heat and Moisture Exchange (HME) filter, VAP bundle in ICU, endotracheal tube occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 72-hour HME exchange interval group | Experimental | Other: 72-hour HME exchange interval groupIntervention 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 | Active comparator | Other: 24-hour HME exchange interval groupControl group: daily care will be provided according to the local standards, with an HME exchange interval every 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 72-hour HME exchange interval groupAll 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 | 72-hour HME exchange interval group |
| 24-hour HME exchange interval groupAll 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. | Other | 24-hour HME exchange interval group |
Primary outcome
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).
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.
4 secondary outcomes
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
ATB exposure analysis
Time frame: 3 months
Length of ICU stay in days
Time frame: 3 months
Number of ventilator-free days.
Time frame: at 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kateřina Jiroutková principal investigator
3rd Faculty of Medicine, Charles University and FNKV, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 72-hour HME exchange interval group and 24-hour HME exchange interval group in people with VAP - Ventilator Associated Pneumonia, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Šárka Línková (+420 723 638 719, sarka.franta@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of HME-associated adverse events (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.