RECRUITINGINTERVENTIONAL

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

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥18 years 2. In-patient in ICU and expected to stay \> 3 days 3. Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation ≥ 72h 4. Clinical Pulmonary Infection score (CPIS) less than six at the baseline 5 No history and symptoms of aspiration at the baseline Who Should NOT Join This Trial: 1. Suspected pulmonary infection on admission and in the first 48 hours of mechanical ventilation 2. Pregnancy 3. Acute respiratory distress syndrome 4. Body temperature \< 32°C 5. Airway bleeding or other contraindications for the use of HME 6. An early decision of treatment withdrawal Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age ≥18 years 2. In-patient in ICU and expected to stay \> 3 days 3. Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation ≥ 72h 4. Clinical Pulmonary Infection score (CPIS) less than six at the baseline 5 No history and symptoms of aspiration at the baseline Exclusion Criteria: 1. Suspected pulmonary infection on admission and in the first 48 hours of mechanical ventilation 2. Pregnancy 3. Acute respiratory distress syndrome 4. Body temperature \< 32°C 5. Airway bleeding or other contraindications for the use of HME 6. An early decision of treatment withdrawal

Treatments Being Tested

OTHER

72-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.

OTHER

24-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.

Locations (1)

3rd Faculty of Medicine and FNKV

Prague, Česká Republika, Czechia