Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units: A Randomized, Controlled, Cluster, Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 12
- 主要终点
- Antimicrobial utilization at the ICU level
研究概览
简要总结
Healthcare-associated infections (HAIs) remain a major problem in intensive care units (ICUs), driven by environmental contamination with multidrug-resistant organisms that persist despite routine manual cleaning. While hydrogen peroxide aerosolization and ultraviolet-C light devices have shown promise in reducing surface contamination, current evidence is inconsistent, mostly derived from single-center studies, and rarely linked to patient-centered outcomes.
The investigators will conduct this cluster-randomized, crossover trial in 12 Brazilian ICUs. Each ICU will sequentially implement three strategies: (1) usual surface disinfection; (2) usual surface disinfection followed by hydrogen peroxide aerosolization at 7.9% concentration, applied through a dedicated device inside a protective tent during terminal cleaning of patient beds; and (3) usual surface disinfection followed by automated ultraviolet-C irradiation, also applied under the same tent to shield adjacent occupied beds.
The primary outcome will be the antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days, with secondary outcomes including HAI incidence rate, environmental contamination with multidrug-resistant organisms, specific HAIs incidence rate (associated-ventilator pneumonia, central-line associated bloodstream infection, and catheter-associated urinary tract infection), and ICU length of stay costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •All patients aged 18 years and older who will be admitted to the participating ICUs
排除标准
- •Patients under 18 years
- •ICUs that use peroxide hydrogen or ultraviolet light for surface disinfection as part of their protocol
研究组 & 干预措施
Surface disinfection with irradiation of ultraviolet light
The hygiene team of each participating ICU will use a specific device, requiring no manipulation, for irradiating UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning. To prevent UV irradiation from reaching occupied beds and other areas of the ICU, the same tent described in the "peroxide hydrogen" arm.
干预措施: Irradiation of ultraviolet light (Other)
Usual disinfection
The control group will perform standard cleaning and disinfection of the beds and the environment according to their previous protocols, using the usual products.
Surface disinfection with aerosolized hydrogen peroxide
The hygiene team of each participating ICU will spray aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge. As peroxide hydrogen aerosol can be irritating to people nearby, we will use a tent designed to cover the bed and nearby equipment during peroxide hydrogen disinfection, thus preventing aerosols from spreading to other beds and other areas of ICUs where beds are not in closed rooms.
干预措施: Aerosol of hydrogen peroxide (Other)
结局指标
主要结局
Antimicrobial utilization at the ICU level
时间窗: 3 months
Antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days
Duration of antimicrobial therapy
时间窗: 3 months
Number of days each included patient used antimicrobial therapy during ICU admission
次要结局
- Healthcare-associated infections(3 months)
- Incidence density of catheter-associated urinary tract infection(3 months)
- Intensive care unit length of stay costs(3 months)
- Contamination of environmental surfaces by multi-resistant microorganisms(3 months)
- Incidence density of ventilator-associated pneumonia(3 months)
- Incidence density of central line-associated bloodstream infections(3 months)