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Completed

NCT Number: NCT07077499

Cleaning Efficacy of Pulsed Vacuum Device on Rigid Endoscopic Instruments

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.

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Key information

Conditions

Post-Surgical Contamination of Rigid Endoscopic Instruments

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shijiazhuang Maternal and Child Health Hospital

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rigid endoscopic instruments scheduled for post-operative cleaning.
  • Types of instruments included: laparoscopes, hysteroscopes, arthroscopes, nephroscopes, prostate resection scopes, and thoracoscopes.

Treatment and study plan

Pulsed Vacuum Cleaning and Disinfection Device

Device

After manual pre-treatment, instruments were placed into the pulsed vacuum cleaning and disinfection machine (Shandong Xinhua Medical, Model PC-150L). The automated program included pulsed vacuum cleaning, rinsing, thermal disinfection (93°C for 2.5 minutes), and vacuum drying.

Vacuum Ultrasonic Cleaner

Device

After manual pre-treatment, instruments were cleaned in a vacuum ultrasonic cleaner (Shandong Xinhua Medical, Model super-6000) with a multi-enzyme solution for a minimum of 5 minutes. This was followed by a separate process in a spray cleaning and disinfection machine for rinsing and drying.

Primary outcomes

  1. Protein Residue Detection

    Time frame: 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.

  2. Cleaning Qualification Rate

    Time frame: 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.

Secondary outcomes

  1. Cleaning Time

    Time frame: Assessed during a single time point event (the cleaning procedure on Day 0). The duration of the measurement is approximately 60 to 90 minutes.

    Total time required to process all 400 instruments in each group, from the start of manual pre-treatment to the completion of the final drying step. Unit: Minutes.

  2. Instrument Damage Rate

    Time frame: Assessed at a single time point: immediately after the completion of the single cleaning procedure on Day 0.

    The number and percentage of instruments found to be damaged (e.g., deformation, breakage) after the complete cleaning and drying cycle in each group.

Sponsors and collaborators

Lead sponsor

Xue Wang

Other

Registry information

Official study title

Analysis of the Cleaning Effect of Pulsed Vacuum Cleaning and Disinfection Device on Rigid Endoscopic Instruments

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.