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

Active, not recruiting

• Conditions: Biosafety Protection; Infectious Diseases

• Registration Number: NCT06697379
• Lead Sponsor: Minghui Li

Brief Summary

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

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 Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance evaluation of medical protective clothing	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.

Secondary Outcome Measures

Name	Time	Method
Protective headgear performance evaluation	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

Trial Locations

Locations (1)

Capital medical university; 🇨🇳 Beijing, Beijing, China