Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard
Sponsor
Universidad Complutense de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT04391010
Collaborator
(none)
63
1
2
10
191.8
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard: A Randomized Clinical Trial
Actual Study Start Date
:
May 22, 2020
Actual Primary Completion Date
:
Jun 1, 2020
Actual Study Completion Date
:
Jun 1, 2020
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Fit factor [Change from baseline fit factor immediately after intervention]
Particles count into masks compared to particles count outside of the masks
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthcare providers
Exclusion Criteria:
-
Pulmonary diseases
-
Pregnant women
-
Not sign the informed consent form
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidad Complutense de Madrid | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Universidad Complutense de Madrid
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
César Calvo Lobo,
Principal Investigator,
Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT04391010
Other Study ID Numbers:
- UCM Respirators Fit Factor
First Posted:
May 18, 2020
Last Update Posted:
Jun 2, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No