Community Health WorkersNCT04391010
Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard
A study testing Surgical masks and Filtering respirators in people with Community Health Workers and Filtration, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community Health Workers, Filtration, Masks
- What is being tested?
- Surgical masks and Filtering respirators
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 22 May 2020to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare providers
Who cannot join
- Pulmonary diseases
- Pregnant women
- Not sign the informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Community Health Workers, Filtration, Masks
- Being tested
- Surgical masks, Filtering respirators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical masksOther
Surgical masks will be applied in health care providers
Filtering respiratorsOther
Filtering respirators will be applied in health care providers
| Study group | Role | What they receive |
|---|---|---|
| Health care providers with beard | Other | Not described Receives: Other: Surgical masks; Other: Filtering respirators |
| Health care providers without beard | Other | Not described Receives: Other: Surgical masks; Other: Filtering respirators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit factor
Particles count into masks compared to particles count outside of the masks
Measured: Change from baseline fit factor immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start22 May 2020
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Health WorkersStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391010
- Sponsor's protocol ID
- UCM Respirators Fit Factor
- Status last verified
- Jun 2020
- First submitted
- 12 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Respirators Fit Factor in Healthcare Providers With and Without Beard: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04391010
- Acronym / sponsor ID
- UCM Respirators Fit Factor
- Conditions
- Community Health Workers, Filtration, Masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care providers with beard | Other | Other: Surgical masks, Other: Filtering respirators |
| Health care providers without beard | Other | Other: Surgical masks, Other: Filtering respirators |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare providers
Key exclusion criteria (3 listed)
- Pulmonary diseases
- Pregnant women
- Not sign the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical masksSurgical masks will be applied in health care providers | Other | Health care providers with beard, Health care providers without beard |
| Filtering respiratorsFiltering respirators will be applied in health care providers | Other | Health care providers with beard, Health care providers without beard |
Primary outcome
Fit factor
Time frame: Change from baseline fit factor immediately after intervention
Particles count into masks compared to particles count outside of the masks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical masks and Filtering respirators in people with Community Health Workers and Filtration, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fit factor (time frame: Change from baseline fit factor immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.