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Active, not recruitingNCT06697379Updated Nov 20, 2024

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

An observational study in Biosafety Protection and Infectious Diseases, sponsored by Minghui Li. Active, not recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Minghui Li · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
100
Sex
All
01

Study summary

Systematically evaluate the safety performance, intelligent application effect and experience of PPE developed in different scenarios.

Read the 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.

02

Conditions studied

  • Biosafety Protection
  • Infectious Diseases
03

In context

Communicable Diseases

4,451 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's planned enrollment of 100 is below the median of 244 across 1,499 observational studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Minghui Li is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • NA
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Performance evaluation of medical protective clothing

    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.

    Time frame: 3 years

Secondary outcomes

  1. Protective headgear performance evaluation

    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

    Time frame: 3 years

07

Study locations

1 site
  • Capital medical university
    Beijing, Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06697379
Lead sponsor
Minghui Li
Responsible party
Minghui Li (Doctor, Professor, Beijing Municipal Administration of Hospitals) — Sponsor-investigator
First posted
Nov 20, 2024
Start date
Jan 1, 2023
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Nov 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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