Effects of Oral Care With 3% Hydrogen Peroxide (Oroxid®) on the Lower Respiratory Tract Microbial Colonisation in Mechanically Ventilated Adult Critically Ill Patients (HyPer-MICROBE Trial); a Single-centre, Randomised, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h.
研究概览
简要总结
HyPerMICROBE is a single-centre, controlled, randomised, prospective, superiority clinical trial to compare the efficacy of daily oral care with 3% hydrogen peroxide (Oroxid®) versus standard of care (0.2% chlorhexidine digluconate) on the cumulative incidence of lower respiratory tract microbial colonisation in mechanically ventilated adult 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. Chlorhexidine for oral care in critically ill has no clear impact on VAP rates and may cause harm. 3% hydrogen peroxide (Oroxid) could be a promising substitute.
Aim: To test effectivity and safety of 3% hydrogen peroxide solution on ventilator-associated complications
Design: Prospective, single center, parallel group randomised controlled trial. Subjects: ICU patients (general ICU)
Treatment in the intervention group: daily oral care with 3% hydrogen peroxide
Control group: Standard-of-care protocolised daily oral care with 0,2% chlorhexidine
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 mouthwash type - nature of the fluid, its odour etc.), 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 of ICU and expected to stay > 5 days
- •Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation (MV) ≥ 72h
- •Clinical Pulmonary Infection score (CPIS) less than 6 at the baseline
- •No history and symptoms of aspiration at the baseline
排除标准
- •ATB therapy of respiratory infection on admission
- •Suspected pulmonary infection on admission and in the first 48h of mechanical ventilation
- •Oral ulcers or injuries
- •Patient with a history of hydrogen peroxide allergy
研究组 & 干预措施
Hydrogen Peroxide
Intervention group: daily oral care will be provided according to the local standard, with 3% hydrogen peroxide, oral assessment and teeth brushing will be completed twice daily (morning and evening).
干预措施: Oroxid® (Drug)
Chlorhexidine
Control group: daily oral care will be provided according to the local standard, with 0,2% chlorhexidine, oral assessment and teeth brushing will be completed twice daily (morning and evening).
干预措施: Chlorhexidine mouthwash (Drug)
结局指标
主要结局
Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h.
时间窗: 18 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
- Intraoral complications, reported using the Bedside oral exam (BOE) score, validated and adopted for ICU.(will be measured at 24 hours (T1), day 3 (T2), day 7 (T3) and day 14 (T4) after admission)
- Differences in the relative risk of infection related ventilator associated complications (IVAC)(18 months)
- ATB exposure at discharge(From the date of enrolment through to the date of ICU discharge, approximately 28 days)
- Length of ICU stay in days(at 3 months)
- Number of ventilator-free days;(at 28 days)
研究者
Kateřina Jiroutková
Principal Investigator, Kateřina Jiroutková, MD, PhD, EDAIC
Charles University, Czech Republic