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

Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Masks; Community Health Workers; Filtration
• Intervention / Treatment: Other: Surgical masks; Other: Filtering respirators

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthcare providers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Health care providers with beard	Other: Surgical masks; Surgical masks will be applied in health care providers; Other: Filtering respirators; Filtering respirators will be applied in health care providers
Other: Health care providers without beard	Other: Surgical masks; Surgical masks will be applied in health care providers; Other: Filtering respirators; Filtering respirators will be applied in health care providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fit factor	Particles count into masks compared to particles count outside of the masks	Change from baseline fit factor immediately after intervention

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: UCM Respirators Fit Factor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No