Key Technology Research and Application Demonstration of Individual Protective Equipment for High-Level Biosafety Laboratories

November 18, 2024 updated by: Minghui Li
Systematically evaluate the safety performance, intelligent application effect and experience of PPE developed in different scenarios.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

In high-level biosafety laboratories, the National Center for Infectious Disease Medicine, medical consortiums and other national platforms, systematic assessment of the project developed individual physical protection equipment in different scenarios of the safety performance, the intelligent application of the effect and the use of experience, the assessment of the indicators covering the protection performance, safety, stability, comfort, environmental protection, intelligence, ease of operation, including but not limited to local breakage protection performance, Aerosol protection performance, airtightness, liquid penetration performance, differential pressure stability, noise value, air supply flow, ease of wear and removal, ease of movement, ease of operation, degradability, degree of intelligence, etc., and ultimately determine the technical indicators and testing methods of individual physical protective equipment, and establish evaluation technical standards. Based on the determined technical indexes and testing methods of individual physical protective equipment, we will carry out parallel comparative evaluation of similar foreign imported equipment, and form a technical research report on the evaluation of the performance of relevant protective equipment. Optimise the quantitative performance indexes of PPE for domestic shortcomings and weaknesses. Prepare standard operation norms and technical standards for individual physical protective equipment.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories

Description

Inclusion Criteria:

  • Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance evaluation of medical protective clothing
Time Frame: 3 years

Evaluate the performance of self-developed equipment versus commercially developed equipment, such as protective clothing, hoods, boots and gloves.

Protective clothing:

Surface moisture resistance: according to the standard including GB/T 4745-1997 on the level of water, the protective clothing outside the water level is not less than level 3 Hydrostatic pressure: according to GB/T 4744-1997, the hydrostatic pressure is not less than 1.67kPa or 17cmH2O.

Moisture permeability: according to GB/T 12704-1991, the moisture permeability is not less than 2500g/(m²-24h).

Water staining test: according to GB/T 4745-1997, the outer water staining level is not less than 3.

Microbiological barrier performance: the protective clothing should meet the requirements of microbiological indicators in GB 15979-2002 to ensure that it can effectively block the invasion of bacteria, viruses and other microorganisms.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protective headgear performance evaluation
Time Frame: 3 years

Protective hood:

Bacterial filtration efficacy expressed as BFE Rupture strength and elongation at break evaluated in Newtons Moisture permeability is evaluated by m²-24h. Water exposure test: According to GB/T 4745-1997, the external water exposure level should not be less than grade
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minghui Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Estimated)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022YFC2603505

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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