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

NCT06410664 | Recruiting

• 1 other identifier: VP/47/0/2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

VAP - Ventilator Associated Pneumonia

Keywords

pneumonia; Heat and Moisture Exchange (HME) filter; VAP bundle in ICU; endotracheal tube occlusion

Outcome Measures

Primary Outcomes (2)

• Presence of HME-associated adverse events

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

  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.

  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.

  3 months

• ATB exposure analysis

  3 months

• Length of ICU stay in days

  3 months

• Number of ventilator-free days.

  at 28 days

Other Outcomes (5)

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

  3 months

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

  up to 30 days

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

  up to 30 days

Study Arms (2)

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

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

Other: 24-hour HME exchange interval group

Interventions

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.

72-hour HME exchange interval group

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.

24-hour HME exchange interval group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

3rd Faculty of Medicine and FNKV

Prague, Česká Republika, 110 00, Czechia

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Kateřina Jiroutková

  3rd Faculty of Medicine, Charles University and FNKV, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Šárka Línková

CONTACT

+420 723 638 719; sarka.franta@seznam.cz

Adéla Jiroudkova

CONTACT

+420 602 145 168; adela.jiroudkova@ruk.cuni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, nurses can't be blinded to allocation (the frequency of HME exchange), but are strongly inculcated not to disclose the allocation status of the participant at the follow-up assessments. As the ICU is paperless and fully computerised, the data in the computer can be acquired and analysed by the researchers without having access to information about the allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kateřina Jiroutková, MD, PhD, DESAIC, Charles University, Czech Republic, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 13, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

CZ (1)