Cleaning Efficacy of Pulsed Vacuum Device on Rigid Endoscopic Instruments

Xue Wang

Status: Completed

Conditions: Post-Surgical Contamination of Rigid Endoscopic Instruments

Treatments: Device: Vacuum Ultrasonic Cleaner; Device: Pulsed Vacuum Cleaning and Disinfection Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07077499

2024039

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 800 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Pulsed Vacuum Cleaning Group

Experimental group

Description:

A total of 400 rigid endoscopic instruments were cleaned using a pulsed vacuum cleaning and disinfection device following manual pre-treatment. The process integrated cleaning, rinsing, disinfection, and vacuum drying into a single automated cycle.

Treatment:

Device: Pulsed Vacuum Cleaning and Disinfection Device

Ultrasonic Cleaning Group

Active Comparator group

Description:

A total of 400 rigid endoscopic instruments were cleaned using a conventional vacuum ultrasonic cleaner, followed by a separate spray cleaning and drying process, after manual pre-treatment.

Treatment:

Device: Vacuum Ultrasonic Cleaner