Covid19NCT05079308
Clinical Trial on the Efficacy of Different Masks With and Without a Peripheral Sealing Device, Against Covid-19
A study testing Peripheral sealing device for surgical mask or filtering face piece and IIR Surgical mask with Filtering face piece in people with Covid19 and Personal Protective Equipment, run by University of the Balearic Islands at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Personal Protective Equipment
- What is being tested?
- Peripheral sealing device for surgical mask or filtering face piece and IIR Surgical mask with Filtering face piece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 31 Aug 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial on the Level of Respiratory Protection of Surgical Face Masks and Filtering Face Pieces (FFP2), With and Without a Peripheral Sealing Device, Against Covid-19
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.
Read the detailed description
The purpose of the research is to determine if there are statistically significant differences in the level of respiratory protection in situations of high risk against the contagion of Covid-19 or other harmful biological agents, in subjects who use filtering face pieces (FFP2) with or without a peripheral sealing device (AMS), Type IIR surgical face masks with or without a AMS, and subjects using the FFP2 filtering face mask simultaneously with the Type IIR surgical face mask. For this, a total of 210 individuals were selected from different environments in order to attain diversity, while controlling for representativeness bias. They were selected from the ADEMA University School - UIB, nursing staff from the Infectious Diseases Service at Son Espases University Hospital, 112 Emergency Service of the Autonomous Community of the Balearic Islands and the General Directorate of Planning and Centers of the Ministry of Education and Professional Training (Balearic Islands, Spain).
Participants were assigned to one of the 5 groups and subgroups, after accepting their participation in the study voluntarily and freely by signing the consent form approved by the CEI-IB.
To evaluate the adjustment of the respiratory protective equipment with and without the personalized peripheral sealing device (AMS), a sweet sensitivity test was performed with the 3M FT-10 Qualitative Fit-Test Kit (Saint Paul, Minnesota, USA), which complies with the current standards of the Occupational Security and Health Administration (OSHA) and according to the protocol described in Riutord-Sbert et al. (2021). During the qualitative fit test, a total of seven mobility exercises of 60 seconds each were performed, and the nebulizer was squeezed, every 30 seconds:
Phase 1 - Normal breathing Phase 2 - Slow and deep breathing Phase 3 - Breathing whilst moving the head to both sides Phase 4 - Breathing whilst moving the head up and down Phase 5 - Breathing spelling the alphabet Phase 6 - Breathing whilst moving up and down from the waist Phase 7 - Normal breathing
If the fit test was completed within 7 minutes without the individual having detected the sweet taste, the seal was considered optimal or adequate and the experiment was graded as APPROVED. If the subject detected the sweet test before seven minutes, the adjustment was considered inadequate and was scored as FAILED, noting the time it took to detect the sweet taste as established in the protocol of the 3M FT-10 Fit test (Riutord-Sbert et al. 2021).
- Conditions
- Covid19, Personal Protective Equipment
- Being tested
- Peripheral sealing device for surgical mask or filtering face piece, IIR Surgical mask with Filtering face piece
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral sealing device for surgical mask or filtering face pieceDevice
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).
IIR Surgical mask with Filtering face pieceDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Filtering face piece with peripheral sealing device | Experimental | Individuals using the Filtering face Piece (FFP2) with the Peripheral Sealing Device (AMS). Receives: 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; Receives: 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; Receives: 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; Receives: 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. Receives: Device: IIR Surgical mask with Filtering face piece |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 months
Secondary outcomes (1)
Qualitative analysis of the respiratory protective equipment in protecting against the simulated aerosol: intragroup comparison
A qualitative analysis will be performed in order to evaluate whether the respiratory protective equipment (RPE) tested in the study are effective in protecting the individuals from a simulated aerosol environment. Subjects of the Subgroup FFP2 with AMS with the subjects of the Subgroup SM with AMS; the subjects of the Subgroup FFP2 with AMS with those of the subjects of the Group FFP2+SM and, finally, the subjects of the SM with AMS with the subjects of the FFP2+SM Group. There is only one outcome measure: evaluate if the individuals are able to sense the aeresol or not.
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Mar 2021
- Primary completion30 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079308
- Sponsor's protocol ID
- UBalearicIslands
- Status last verified
- Oct 2021
- First submitted
- 8 Sep 2021
- Last updated
- 26 Oct 2021
- 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 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Level of Respiratory Protection of Surgical Face Masks and Filtering Face Pieces (FFP2), With and Without a Peripheral Sealing Device, Against Covid-19
- ClinicalTrials.gov ID
- NCT05079308
- Acronym / sponsor ID
- UBalearicIslands
- Conditions
- Covid19, Personal Protective Equipment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 15 Oct 2021 (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.
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.
Detailed description
The purpose of the research is to determine if there are statistically significant differences in the level of respiratory protection in situations of high risk against the contagion of Covid-19 or other harmful biological agents, in subjects who use filtering face pieces (FFP2) with or without a peripheral sealing device (AMS), Type IIR surgical face masks with or without a AMS, and subjects using the FFP2 filtering face mask simultaneously with the Type IIR surgical face mask. For this, a total of 210 individuals were selected from different environments in order to attain diversity, while controlling for representativeness bias. They were selected from the ADEMA University School - UIB, nursing staff from the Infectious Diseases Service at Son Espases University Hospital, 112 Emergency Service of the Autonomous Community of the Balearic Islands and the General Directorate of Planning and Centers of the Ministry of Education and Professional Training (Balearic Islands, Spain).
Participants were assigned to one of the 5 groups and subgroups, after accepting their participation in the study voluntarily and freely by signing the consent form approved by the CEI-IB.
To evaluate the adjustment of the respiratory protective equipment with and without the personalized peripheral sealing device (AMS), a sweet sensitivity test was performed with the 3M FT-10 Qualitative Fit-Test Kit (Saint Paul, Minnesota, USA), which complies with the current standards of the Occupational Security and Health Administration (OSHA) and according to the protocol described in Riutord-Sbert et al. (2021). During the qualitative fit test, a total of seven mobility exercises of 60 seconds each were performed, and the nebulizer was squeezed, every 30 seconds:
Phase 1 - Normal breathing Phase 2 - Slow and deep breathing Phase 3 - Breathing whilst moving the head to both sides Phase 4 - Breathing whilst moving the head up and down Phase 5 - Breathing spelling the alphabet Phase 6 - Breathing whilst moving up and down from the waist Phase 7 - Normal breathing
If the fit test was completed within 7 minutes without the individual having detected the sweet taste, the seal was considered optimal or adequate and the experiment was graded as APPROVED. If the subject detected the sweet test before seven minutes, the adjustment was considered inadequate and was scored as FAILED, noting the time it took to detect the sweet taste as established in the protocol of the 3M FT-10 Fit test (Riutord-Sbert et al. 2021).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Filtering face piece with peripheral sealing device | Experimental | Device: Peripheral sealing device for surgical mask or filtering face pieceIndividuals using the Filtering face Piece (FFP2) with the Peripheral Sealing Device (AMS). |
| Filtering face piece without peripheral sealing device | Active comparator | Device: Peripheral sealing device for surgical mask or filtering face pieceIndividuals using the Filtering face Piece (FFP2) without the AMS; |
| IIR surgical mask with peripheral sealing device | Experimental | Device: Peripheral sealing device for surgical mask or filtering face pieceIndividuals using the Surgical mask (SM) with the AMS; |
| IIR surgical mask without peripheral sealing device | Active comparator | Device: Peripheral sealing device for surgical mask or filtering face pieceIndividuals using the Surgical mask (SM) without the AMS; |
| Filtering face piece with IIR surgical mask | Experimental | Device: IIR Surgical mask with Filtering face pieceindividuals using a FFP2 with a SM over it, simultaneously, without the AMS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Peripheral sealing device for surgical mask or filtering face pieceThe 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). | Device | 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 pieceThe 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). | Device | Filtering face piece with IIR surgical mask |
Primary outcome
Qualitative analysis of the respiratory protective equipment in protecting against the simulated aerosol: intergroup comparison
Time frame: up to 5 months
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.
1 secondary outcome
Qualitative analysis of the respiratory protective equipment in protecting against the simulated aerosol: intragroup comparison
Time frame: up to 5 months
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 26 Oct 2021.
- 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 Peripheral sealing device for surgical mask or filtering face piece and IIR Surgical mask with Filtering face piece in people with Covid19 and Personal Protective Equipment, run by University of the Balearic Islands 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 1 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 26 Oct 2021. 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?
Qualitative analysis of the respiratory protective equipment in protecting against the simulated aerosol: intergroup comparison (time frame: up to 5 months). 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 26 Oct 2021.