Biosafety ProtectionNCT06697379
Key Technology Research and Application Demonstration of Individual Protective Equipment for High-Level Biosafety Laboratories
An observational study of Biosafety Protection and Infectious Diseases, run by Minghui Li at 1 site in China.
Trial summary
Systematically evaluate the safety performance, intelligent application effect and experience of PPE developed in different scenarios. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biosafety Protection, Infectious Diseases
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories
Who may be able to join
- Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Biosafety Protection, Infectious Diseases
- Medical subject headings
- Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biosafety ProtectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minghui Li
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Minghui Li, Beijing Municipal Administration of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697379
- Sponsor's protocol ID
- 2022YFC2603505
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Technology Research and Application Demonstration of Individual Protective Equipment for High-Level Biosafety Laboratories
- ClinicalTrials.gov ID
- NCT06697379
- Acronym / sponsor ID
- 2022YFC2603505
- Conditions
- Biosafety Protection, Infectious Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minghui LiOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories
Key inclusion criteria (1 listed)
- Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Protective headgear performance evaluation
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biosafety Protection and Infectious Diseases, run by Minghui Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance evaluation of medical protective clothing (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.