Changes in Capillary Carbon Dioxide Partial Pressure (pCO2) While Wearing FFP2 / FFP3 Masks
NCT ID: NCT04980820
Last Updated: 2022-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
200 participants
INTERVENTIONAL
2021-07-19
2022-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Furthermore, changes in the capillary oxygen partial pressure, the subjective respiratory effort and the breathing rate are measured.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The aim of this prospective cross-over study is to compare the PcCO2 measured by capillary blood sampling from medical staff while wearing an FFP2 or FFP3 mask. The PcCO2 determined without a mask serves as a reference value. While no mask is worn, the PcCO2, the subjective respiratory effort, the breathing rate and the capillary oxygen partial pressure (PcO2) is measured. The study participants then wear an FFP2 or FFP3 mask for one hour, and the same parameters are collected. Subsequently, the participant switches to an FFP3 or FFP2 mask, and the last measurement is conducted after one hour.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
2. arm: starts with no mask - FFP3 mask - FFP2 mask
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FFP2
This arm starts with a FFP2 mask and switches to a FFP3 mask.
No mask
The participant is asked to wear no mask for 10 minutes.
Filtering face mask 2 (FFP2)
The participant is asked to wear a FFP2 mask for 1 hour during work.
Filtering face mask 3 (FFP3)
The participant is asked to wear a FFP3 mask for 1 hour during work.
FFP3
This arm starts with a FFP3 mask and switches to a FFP2 mask.
No mask
The participant is asked to wear no mask for 10 minutes.
Filtering face mask 2 (FFP2)
The participant is asked to wear a FFP2 mask for 1 hour during work.
Filtering face mask 3 (FFP3)
The participant is asked to wear a FFP3 mask for 1 hour during work.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No mask
The participant is asked to wear no mask for 10 minutes.
Filtering face mask 2 (FFP2)
The participant is asked to wear a FFP2 mask for 1 hour during work.
Filtering face mask 3 (FFP3)
The participant is asked to wear a FFP3 mask for 1 hour during work.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* oral and written consent to take part voluntarily in this trial
Exclusion Criteria
* not Coronavirus disease-19 vaccinated
* pregnancy
* breastfeeding
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Vienna
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David M Baron, MD
Assoc. Prof. PD Dr. David Baron, EDIC
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Georg Röder, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna, Dept. of Anaesthesiology, Critical Care and Pain Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Vienna
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Paules CI, Marston HD, Fauci AS. Coronavirus Infections-More Than Just the Common Cold. JAMA. 2020 Feb 25;323(8):707-708. doi: 10.1001/jama.2020.0757. No abstract available.
Fletcher SJ, Clark M, Stanley PJ. Carbon dioxide re-breathing with close fitting face respirator masks. Anaesthesia. 2006 Sep;61(9):910. doi: 10.1111/j.1365-2044.2006.04767.x. No abstract available.
Ozdemir L, Azizoglu M, Yapici D. Respirators used by healthcare workers due to the COVID-19 outbreak increase end-tidal carbon dioxide and fractional inspired carbon dioxide pressure. J Clin Anesth. 2020 Nov;66:109901. doi: 10.1016/j.jclinane.2020.109901. Epub 2020 May 22.
Kim JH, Benson SM, Roberge RJ. Pulmonary and heart rate responses to wearing N95 filtering facepiece respirators. Am J Infect Control. 2013 Jan;41(1):24-7. doi: 10.1016/j.ajic.2012.02.037. Epub 2012 Sep 1.
Related Links
Access external resources that provide additional context or updates about the study.
Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1144/2021
Identifier Type: -
Identifier Source: org_study_id