NCT04391010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

May 22, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 2, 2020

Status Verified

June 1, 2020

Enrollment Period

10 days

First QC Date

May 12, 2020

Last Update Submit

June 1, 2020

Conditions

Community Health WorkersFiltrationMasks

Outcome Measures

Primary Outcomes (1)

  • Fit factor

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

    Change from baseline fit factor immediately after intervention

Study Arms (2)

Health care providers with beard

OTHER
Other: Surgical masksOther: Filtering respirators

Health care providers without beard

OTHER
Other: Surgical masksOther: Filtering respirators

Interventions

Surgical masksOTHER

Surgical masks will be applied in health care providers

Health care providers with beardHealth care providers without beard
Filtering respiratorsOTHER

Filtering respirators will be applied in health care providers

Health care providers with beardHealth care providers without beard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare providers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Interventions

N95 Respirators

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesRespiratory Protective DevicesPersonal Protective EquipmentProtective DevicesSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 18, 2020

Study Start

May 22, 2020

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)