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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Presence of HME-associated adverse events
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Suspected pulmonary infection on admission and in the first 48 hours of mechanical ventilation
- •Acute respiratory distress syndrome
- •Body temperature < 32°C
- •Airway bleeding or other contraindications for the use of HME
- •An early decision of treatment withdrawal
研究组 & 干预措施
72-hour HME exchange interval group
Intervention group: daily care will be provided according to the local standards, with an HME exchange interval every 72 hours
干预措施: 72-hour HME exchange interval group (Other)
24-hour HME exchange interval group
Control group: daily care will be provided according to the local standards, with an HME exchange interval every 24 hours
干预措施: 24-hour HME exchange interval group (Other)
结局指标
主要结局
Presence of HME-associated adverse events
时间窗: 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.
时间窗: 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.
次要结局
- 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)
- Number of ventilator-free days.(at 28 days)
- ATB exposure analysis(3 months)
- Length of ICU stay in days(3 months)
研究者
Kateřina Jiroutková
Kateřina Jiroutková, MD, PhD, DESAIC, Charles University, Czech Republic, Principal Investigator
Charles University, Czech Republic