HypoxiaNCT05188651
Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic
An observational study of Hypoxia and Hypercapnia, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
aim of this research is to evaluate the effects of FFP2/N95 masks on peripheral oxygen saturation and pulse rate in dental professionals Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Hypercapnia, COVID-19 Pandemic
- What is being tested?
- face masks
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2022to 1 Sep 2022
- Phase
- Observational
- 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
Study population: all kind of dental professionals
Who may be able to join
- dental professionals
Who cannot join
- subjects not signing informed consent
- subjects unable to wear facemasks due to underlying conditions
Trial locations and contacts
1 site in 1 country.
About this study
aim of this research is to evaluate the effects of FFP2/N95 masks on peripheral oxygen saturation and pulse rate in dental professionals
- Conditions
- Hypoxia, Hypercapnia, COVID-19 Pandemic
- Being tested
- face masks
- Medical subject headings
- Hypoxia, Hypercapnia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
face masksBehavioural
wearing face masks
| Study group | Role | What they receive |
|---|---|---|
| dental professionals wearing FFP2/N95 masks | Not described Receives: Behavioral: face masks | |
| dental professionals wearing type IIR fluid resistant surgical masks | Not described Receives: Behavioral: face masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in peripheral oxygen saturation using FFP2/N95 masks
Measured: before wearing face mask, after 30 minutes, after 1 hour, at the end of the clinical activity after 4-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start30 Jan 2022
- Primary completion1 Apr 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Alessandri Bonetti, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188651
- Sponsor's protocol ID
- 4235
- Status last verified
- Mar 2026
- First submitted
- 10 Jan 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05188651
- Acronym / sponsor ID
- 4235
- Conditions
- Hypoxia, Hypercapnia, COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 12 Jan 2022 (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.
aim of this research is to evaluate the effects of FFP2/N95 masks on peripheral oxygen saturation and pulse rate in dental professionals
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dental professionals wearing FFP2/N95 masks | – | Behavioral: face masks |
| dental professionals wearing type IIR fluid resistant surgical masks | – | Behavioral: face masks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all kind of dental professionals
Key inclusion criteria (1 listed)
- dental professionals
Key exclusion criteria (2 listed)
- subjects not signing informed consent
- subjects unable to wear facemasks due to underlying conditions
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 |
|---|---|---|
| face maskswearing face masks | Behavioural | dental professionals wearing FFP2/N95 masks, dental professionals wearing type IIR fluid resistant surgical masks |
Primary outcome
change in peripheral oxygen saturation using FFP2/N95 masks
Time frame: before wearing face mask, after 30 minutes, after 1 hour, at the end of the clinical activity after 4-5 hours
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 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Hypoxia and Hypercapnia, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 2 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 18 Mar 2026. 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 Italy. 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?
change in peripheral oxygen saturation using FFP2/N95 masks (time frame: before wearing face mask, after 30 minutes, after 1 hour, at the end of the clinical activity after 4-5 hours). 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 18 Mar 2026.