Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic
Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Recruiting
CT.gov ID
NCT05188651
Collaborator
(none)
60
1
3
20.3
Study Details
Study Description
Brief Summary
aim of this research is to evaluate the effects of FFP2/N95 masks on peripheral oxygen saturation and pulse rate in dental professionals
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic
Anticipated Study Start Date
:
Jan 1, 2022
Anticipated Primary Completion Date
:
Mar 1, 2022
Anticipated Study Completion Date
:
Apr 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| dental professionals wearing FFP2/N95 masks
|
Behavioral: face masks
wearing face masks
|
| dental professionals wearing type IIR fluid resistant surgical masks
|
Behavioral: face masks
wearing face masks
|
Outcome Measures
Primary Outcome Measures
- change in peripheral oxygen saturation using FFP2/N95 masks [before wearing face mask, after 30 minutes, after 1 hour, at the end of the clinical activity after 4-5 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- dental professionals
Exclusion Criteria:
-
subjects not signing informed consent
-
subjects unable to wear facemasks due to underlying conditions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Policlinico Universitario A. Gemelli | Roma | RM | Italy | 00168 |
Sponsors and Collaborators
- Catholic University of the Sacred Heart
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Anna Alessandri Bonetti,
PhD student, Institute of dental clinic and maxillofacial surgery,
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT05188651
Other Study ID Numbers:
- 4235
First Posted:
Jan 12, 2022
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: