Effectiveness of Respirators Fit Factor in Healthcare Pro... | NCT04391010

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

NCT04391010

Sponsor

Universidad Complutense de Madrid

Status

Completed

Last Update Posted

Jun 2, 2020Actual

Enrollment

63Actual

Phase

Not Applicable

Conditions

Community Health Workers
Filtration
Masks

Interventions

Surgical masks
Filtering respirators

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2020Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

May 12, 2020

First Submission Date that Met QC Criteria

May 15, 2020

First Posted Date

May 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2020

Last Update Posted Date

Jun 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

César Calvo Lobo, Principal Investigator, Universidad Complutense de MadridPrincipal Investigator

Lead Sponsor

Universidad Complutense de MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health care providers with beard	Other		Other: Surgical masks Other: Filtering respirators
Health care providers without beard	Other		Other: Surgical masks Other: Filtering respirators

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical masks	Other	Surgical masks will be applied in health care providers	Health care providers with beard Health care providers without beard

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthcare providers

Exclusion Criteria:

Pulmonary diseases
Pregnant women
Not sign the informed consent form

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad Complutense de Madrid		Madrid		28040	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000087162	N95 Respirators

Ancestor Terms

ID	Term
D058257	Surgical Attire
D004865	Equipment and Supplies, Hospital
D004864	Equipment and Supplies
D012134	Respiratory Protective Devices

Browse Leaves

Not provided

Browse Branches

Not provided