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Evaluation of N95 respirators on fit rate, real-time leakage, and usability among Chinese healthcare workers

Comparison of real-time leakage using traditional and new N95 respirators among Chinese healthcare workers: A phase two randomised cross over trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40115047
Enrollment
200
Registered
2023-05-09
Start date
2021-11-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Prevention to limit the spread of infectious respiratory pathogens to healthcare workers in hospitals during clinical procedures. Not Applicable

Interventions

Traditional respirators refer to the commonly used 3M head-loop respirators in hospitals in Hong Kong, namely the 3M cup-shaped 1860S and the three-panel-designed 1870+. New respirators refer to the

Sponsors

Tung Wah College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthcare workers who are students or staff (with licence) who provide direct care to patients 2. Aged 18 years or above 3. Certified and able to perform standard cardiopulmonary resuscitation for delivery of basic life support or advanced cardiovascular support, those who have completed an accredited institutional training program, and those who perform cardiopulmonary resuscitation in the clinical field. 4. Healthcare workers who obtained a pass of fit tests for one of the traditional N95 respirators (best-fit one) as well as new respirators in the phase1 study

Exclusion criteria

Exclusion criteria: Healthcare workers who have a history of chronic respiratory diseases or medical conditions or medical conditions (e.g., asthma, congestive heart, coronary heart diseases), are pregnant, and have any musculoskeletal diseases that restrict the capacity of cardiopulmonary resuscitation performance.

Design outcomes

Primary

MeasureTime frame
Real-time leakage is measured by two portable aerosol spectrometers by factoring the difference in small particles (0.3µm) between ambient and inside respirators at an average of 30 s intervals while performing cardiopulmonary resuscitation. A total of eight sets within a 4 min procedure.

Secondary

MeasureTime frame
1. Fit rate, which is the proportion of fit factor >100 among total samples with a given respirator measured by a PortaCount respirator fit-tester system (model Pro+ 8038/8040; TSI limited) 2. Mask usability measured using an 11-item Mask Usability Scale to measure wearers' personal feedback on a donned respirator measured at a single time point

Countries

China, Hong Kong

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026