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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04391010
Other study ID # UCM Respirators Fit Factor
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 22, 2020
Est. completion date June 1, 2020

Study information

Verified date June 2020
Source Universidad Complutense de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthcare providers

Exclusion Criteria:

- Pulmonary diseases

- Pregnant women

- Not sign the informed consent form

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Surgical masks
Surgical masks will be applied in health care providers
Filtering respirators
Filtering respirators will be applied in health care providers

Locations

Country Name City State
Spain Universidad Complutense de Madrid Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fit factor Particles count into masks compared to particles count outside of the masks Change from baseline fit factor immediately after intervention
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