CClinicalTrials.gg
CompletedNCT04391010Updated Jun 2, 2020

Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard

An interventional study of Surgical masks and Filtering respirators in Community Health Workers, Filtration and Masks, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-02.

Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study aim will be to determine the fit factor of surgical masks and filtering respirators in healthcare providers with and without beard. A randomized clinical trial will be carried out recruiting a sample of 52 healthcare providers with and without beard. Fit factor will be measured with both surgical masks and filtering respirators and compared between healthcare providers with and without beard.

02

Conditions studied

  • Community Health Workers
  • Filtration
  • Masks
03

In context

Lead sponsor

Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthcare providers

Exclusion criteria

Exclusion Criteria:

  • Pulmonary diseases
  • Pregnant women
  • Not sign the informed consent form
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Other
    Health care providers with beard

    Other: Surgical masks · Other: Filtering respirators

  • Other
    Health care providers without beard

    Other: Surgical masks · Other: Filtering respirators

Interventions

  • OtherSurgical masks

    Surgical masks will be applied in health care providers

  • OtherFiltering respirators

    Filtering respirators will be applied in health care providers

06

What researchers measure

Primary outcomes

  1. Fit factor

    Particles count into masks compared to particles count outside of the masks

    Time frame: Change from baseline fit factor immediately after intervention

07

Study locations

1 site
  • Universidad Complutense de Madrid
    Madrid, 28040, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04391010
Lead sponsor
Universidad Complutense de Madrid
Responsible party
César Calvo Lobo (Principal Investigator, Universidad Complutense de Madrid) — Principal investigator
First posted
May 18, 2020
Start date
May 22, 2020
Primary completion
Jun 1, 2020
Completion
Jun 1, 2020
Last update
Jun 2, 2020

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 completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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