Analysis of the Cleaning Effect of Pulsed Vacuum Cleaning and Disinfection Device on Rigid Endoscopic Instruments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Protein Residue Detection
研究概览
简要总结
This study is a prospective, comparative trial designed to evaluate the cleaning effectiveness of a novel pulsed vacuum cleaning and disinfection device against a conventional vacuum ultrasonic cleaner for rigid endoscopic instruments. Key outcomes measured include cleaning time, cleaning quality (via visual, light source, and ATP inspection), protein residue levels, and instrument damage rate.
详细描述
Rigid endoscopic instruments, due to their complex structure, pose significant challenges for cleaning and sterilization, which is critical for preventing hospital-acquired infections. Traditional methods like ultrasonic and spray cleaning have limitations in efficiency and thoroughness. This study was conducted to assess a newer technology, the pulsed vacuum cleaning and disinfection device, which integrates cleaning, rinsing, disinfection, and drying. A total of 800 rigid endoscopic instruments were divided into two groups: one cleaned with the pulsed vacuum device (Observation Group) and the other with a conventional vacuum ultrasonic cleaner (Control Group). The study aims to provide evidence-based insights into the efficiency, efficacy, and safety of the pulsed vacuum device for clinical application in sterilization supply centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rigid endoscopic instruments scheduled for post-operative cleaning.
- •Types of instruments included: laparoscopes, hysteroscopes, arthroscopes, nephroscopes, prostate resection scopes, and thoracoscopes.
排除标准
- 未提供
结局指标
主要结局
Protein Residue Detection
时间窗: Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0)
The level of residual protein on the instrument surface was measured using the biuret method. Outcomes were categorized as clean, mild, moderate, or severe contamination. The rate of clean instruments was compared between groups.
Cleaning Qualification Rate
时间窗: Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0)
The cleaning effect was evaluated based on the "Hospital Sterilization Supply Center Part 3: Cleaning, Disinfection, and Sterilization Effect Monitoring Standards". Qualification was determined by a composite of three methods: * Visual Inspection: No visible contaminants. * Magnifying Light Source Observation: No visible stains or residues under magnification. * ATP Fluorescence Detection: Relative Light Unit (RLU) value ≤2000. The percentage of instruments passing all three checks was calculated.
Protein Residue Detection
时间窗: Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0)
The level of residual protein on the instrument surface was measured using the biuret method. Outcomes were categorized as clean, mild, moderate, or severe contamination. The rate of clean instruments was compared between groups.
Cleaning Qualification Rate
时间窗: Assessed once per instrument, immediately following the completion of the single cleaning procedure (Day 0)
The cleaning effect was evaluated based on the "Hospital Sterilization Supply Center Part 3: Cleaning, Disinfection, and Sterilization Effect Monitoring Standards". Qualification was determined by a composite of three methods: * Visual Inspection: No visible contaminants. * Magnifying Light Source Observation: No visible stains or residues under magnification. * ATP Fluorescence Detection: Relative Light Unit (RLU) value ≤2000. The percentage of instruments passing all three checks was calculated.
次要结局
- Cleaning Time(Assessed during a single time point event (the cleaning procedure on Day 0). The duration of the measurement is approximately 60 to 90 minutes.)
- Instrument Damage Rate(Assessed at a single time point: immediately after the completion of the single cleaning procedure on Day 0.)
- Cleaning Time(Assessed during a single time point event (the cleaning procedure on Day 0). The duration of the measurement is approximately 60 to 90 minutes.)
- Instrument Damage Rate(Assessed at a single time point: immediately after the completion of the single cleaning procedure on Day 0.)
研究者
Xue Wang
Principal investigator
Shijiazhuang Obstetrics and Gynecology Hospital