Clinical Trial on the Efficacy of Different Masks With and Without a Peripheral Sealing Device, Against Covid-19

NCT05079308 | Completed

• 1 other identifier: UBalearicIslands
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

A significant number of professionals subjected to high-risk situations have been infected by Covid-19, due to the lack of adequate respiratory protection equipment or poor marginal sealing adjustments. Then, the objective of this study is to determine if there are statistically significant differences in the level of respiratory protection of type IIR surgical face masks and filtering face masks, used with and without a peripheral sealing device, against the contagion of Covid-19 or other harmful biological agents. The proposed device is a thermoplastic resin ring composed of a reusable and biodegradable polylactic acid designed to be used in a healthcare environment. The individuals of the study will be submitted to qualitative fit tests, that meet current Ocupational Security and Health Administration (OSHA) standard. The mentioned qualitative fit test uses a sodium saccharin solution to evaluate the respiratory protection equipment in professionals in hospitals, emergency centers, and early childhood education centers.

Conditions

Covid19; Personal Protective Equipment

Outcome Measures

Primary Outcomes (1)

• Qualitative analysis of the respiratory protective equipment in protecting against the simulated aerosol: intergroup comparison

  A qualitative analysis will be performed in order to evaluate whether the respiratory protective equipment is effective in protecting the individuals from a simulated aerosol environment. The individuals will be submitted to 7 different breathing exercises inside of a hood with their open mouth. A nebulizer filled with sacharin solution will be used to simulate an aerosol environment. If the individual do not sense the taste during the whole breathing exercises (total of 7 minutes) the respiratory protective equipment (RPE) used by this individual will be scored as "PASSED". If the individial sense the sweet taste during the 7 minutes, the RPE will be scored as "FAILED". The answer of the individuals using masks with the Peripheral Sealing Device and the controls (individual using masks without the peripheral sealing device) within each group will be compared. There is only one outcome measure: evaluate if the individuals are able to sense the aeresol or not.

  up to 5 months

Secondary Outcomes (1)

• Qualitative analysis of the respiratory protective equipment in protecting against the simulated aerosol: intragroup comparison

  up to 5 months

Study Arms (5)

Filtering face piece with peripheral sealing device

EXPERIMENTAL

Individuals using the Filtering face Piece (FFP2) with the Peripheral Sealing Device (AMS).

Device: Peripheral sealing device for surgical mask or filtering face piece

Filtering face piece without peripheral sealing device

ACTIVE COMPARATOR

Individuals using the Filtering face Piece (FFP2) without the AMS;

Device: Peripheral sealing device for surgical mask or filtering face piece

IIR surgical mask with peripheral sealing device

EXPERIMENTAL

Individuals using the Surgical mask (SM) with the AMS;

Device: Peripheral sealing device for surgical mask or filtering face piece

IIR surgical mask without peripheral sealing device

ACTIVE COMPARATOR

Individuals using the Surgical mask (SM) without the AMS;

Device: Peripheral sealing device for surgical mask or filtering face piece

Filtering face piece with IIR surgical mask

EXPERIMENTAL

individuals using a FFP2 with a SM over it, simultaneously, without the AMS.

Device: IIR Surgical mask with Filtering face piece

Interventions

Peripheral sealing device for surgical mask or filtering face piece DEVICE

The individuals used a Peripheral Sealing Device on a surgical mask or a filtering face piece mask and were submitted to a qualitative fit test, regulated by the Occupational Security and Health Administration (USA).

Filtering face piece with peripheral sealing device; Filtering face piece without peripheral sealing device; IIR surgical mask with peripheral sealing device; IIR surgical mask without peripheral sealing device

IIR Surgical mask with Filtering face piece DEVICE

The individuals used a IIR surgical mask with a filtering face piece mask and were submitted to a qualitative fit test, regulated by the Occupational Security and Health Administration (USA).

Filtering face piece with IIR surgical mask

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• people familiar with the use of face masks, absence of allergy or intolerance to sodium saccharin or materials used, absence of relevant systemic diseases, age between 18-65 years, absence of obvious facial hair and signing the informed consent.

You may not qualify if:

• people not familiar with the use of face masks, presence of allergy or intolerance to sodium saccharin or materials used, presence of relevant systemic diseases, presence of obvious facial hair and not signing the informed consent.

Sponsors & Collaborators

• University of the Balearic Islands: lead

Study Sites (1)

ADEMA University School

Palma de Mallorca, Balearic Islands, 07009, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 15, 2021
• Study Start: March 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)