RecruitingNot ApplicableNCT06410664

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

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

Sponsor

Charles University, Czech Republic

Enrollment

120 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

VAP - Ventilator Associated Pneumonia

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria6

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

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Interventions

OTHER72-hour HME exchange interval group

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.

OTHER24-hour HME exchange interval group

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.