Evaluation of new and conventional N95 fit testing protocols on equivalence and reproducibility

Comparison of new and conventional N95 fit testing protocols for three respirators with different designs: Evaluation of equivalence and reproducibility

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15612510

Enrollment

102

Registered

2025-05-28

Start date

2025-03-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fit testing protocols for three respirators Other

Interventions

This proposed methodological study will have a cross-sectional observational design with repeated measures, according to the Guidelines for Reporting Reliability and Agreement Studies (GRRAS) (https:/

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Students pursuing healthcare disciplines or healthcare workers who are licensed staff members providing direct patient care 2. Aged 18 years or above

Exclusion criteria

Exclusion criteria: 1. Healthcare workers with a documented medical history of chronic respiratory diseases or conditions such as asthma, congestive heart failure, or coronary heart disease 2. Those who are currently pregnant

Design outcomes

Primary

Measure	Time frame
Fit factor (range 0-200) and the pass rate of fit testing (pass or fail). A validated system will be used to measure these variables.	—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

China, Hong Kong

Contacts

Public ContactSimon Ching Lam

simlc@alumni.cuhk.net+852-3468-6854

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026