Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles University, Czech Republic
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Suspected pulmonary infection on admission and in the first 48 hours of mechanical ventilation
Pregnancy
Acute respiratory distress syndrome
Body temperature < 32°C
Trial design
Design model
Parallel
Treatments tested in this trial
72-hour HME exchange interval group
Other interventionAll 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 interventionAll 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: 72-hour HME exchange interval groupExperimental treatment 1 intervention
Group B: 24-hour HME exchange interval groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Presence of HME-associated adverse events
A composite endpoint of nosocomial tracheobronchitis or pneumonia (all-cause, nosocomial and ventilator-associated) or endotracheal tube occlusion).
Time frame
3 months2
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.
Time frame
3 monthsSecondary 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.
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
Time frame
3 months2
ATB exposure analysis
Duration of antibiotics prescribed at discharge.
Time frame
3 months3
Length of ICU stay in days
that is, length in ICU stay in days
Time frame
3 months4
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.
Time frame
at 28 daysOther outcomes
1
The length of ATB therapy until extubation, death or IVAC.
Cumulative percentage of days on the ventilator with ATB until extubation, death or IVAC.
Time frame
3 months2
The values of HME performance in vivo (temperature) during mechanical ventilation.
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.
Time frame
up to 30 days3
The values of HME performance in vivo (humidity) during mechanical ventilation.
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.
Time frame
up to 30 days4
The change in resistance of the HME filter from day 0 to day 2 (72 hours) and during drug nebulisation
The pressure drops over HME filter during mechanical ventilation.
Time frame
up to 30daysSponsors and contacts
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Source ClinicalTrials.gov