- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05188651
Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic
March 17, 2026 updated by: Anna Alessandri Bonetti, Catholic University of the Sacred Heart
aim of this research is to evaluate the effects of FFP2/N95 masks on peripheral oxygen saturation and pulse rate in dental professionals
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RM
-
Roma, RM, Italy, 00168
- Policlinico Universitario A. Gemelli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
all kind of dental professionals
Description
Inclusion Criteria:
- dental professionals
Exclusion Criteria:
- subjects not signing informed consent
- subjects unable to wear facemasks due to underlying conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
dental professionals wearing FFP2/N95 masks
|
wearing face masks
|
|
dental professionals wearing type IIR fluid resistant surgical masks
|
wearing face masks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
before wearing face mask, after 30 minutes, after 1 hour, at the end of the clinical activity after 4-5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2022
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
January 10, 2022
First Posted (Actual)
January 12, 2022
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 17, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Signs and Symptoms, Respiratory
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- COVID-19
- Hypoxia
- Hypercapnia
- Surgical Equipment
- Equipment and Supplies
- Manufactured Materials
- Technology, Industry, and Agriculture
- Protective Devices
- Personal Protective Equipment
- Surgical Attire
- Equipment and Supplies, Hospital
- Masks
Other Study ID Numbers
- 4235
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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