Changes in Capillary Carbon Dioxide Partial Pressure (pCO2) While Wearing FFP2 / FFP3 Masks
Study Details
Study Description
Brief Summary
The aim of this study is to determine whether there are any changes in the carbon dioxide partial pressure in medical staff while wearing a filtering face piece (FFP) 2 or FFP3 mask.
Furthermore, changes in the capillary oxygen partial pressure, the subjective respiratory effort and the breathing rate are measured.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
In the fight against the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), the personal protective equipment (PPE) of medical staff plays a special role. Since the pathogen can be transmitted via droplets, particle-filtering half masks (filtering face piece
- FFP) are a substantial part of the PPE. The current data indicate that there may be an increase in the carbon dioxide partial pressure (PcCO2) in the blood when wearing an FFP2 / 3 mask during routine medical activity.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FFP2 This arm starts with a FFP2 mask and switches to a FFP3 mask. |
Other: No mask
The participant is asked to wear no mask for 10 minutes.
Device: Filtering face mask 2 (FFP2)
The participant is asked to wear a FFP2 mask for 1 hour during work.
Device: Filtering face mask 3 (FFP3)
The participant is asked to wear a FFP3 mask for 1 hour during work.
|
| Experimental: FFP3 This arm starts with a FFP3 mask and switches to a FFP2 mask. |
Other: No mask
The participant is asked to wear no mask for 10 minutes.
Device: Filtering face mask 2 (FFP2)
The participant is asked to wear a FFP2 mask for 1 hour during work.
Device: Filtering face mask 3 (FFP3)
The participant is asked to wear a FFP3 mask for 1 hour during work.
|
Outcome Measures
Primary Outcome Measures
- Change of PcCO2 [1. measurement after 10 minutes without mask, 2. measurement after 1 hour with mask (FFP2/3), 3. measurement after 1 hour with mask (FFP3/2)]
Change of capillary carbon dioxide partial pressure (PcCO2)
Secondary Outcome Measures
- Change of PcO2 [1. measurement after 10 minutes without mask, 2. measurement after 1 hour with mask (FFP2/3), 3. measurement after 1 hour with mask (FFP3/2)]
Change of capillary oxygen partial pressure (PcO2)
- Respiratory rate [1. measurement after 10 minutes without mask, 2. measurement after 1 hour with mask (FFP2/3), 3. measurement after 1 hour with mask (FFP3/2)]
Number of breaths per minute
- Exertion score [1. measurement after 10 minutes without mask, 2. measurement after 1 hour with mask (FFP2/3), 3. measurement after 1 hour with mask (FFP3/2)]
Participant subjective score: "How difficult is it for you to breathe at the moment?"; scale from 1-5, 1= easy, 2= rather easy, 3= moderate, 4= rather hard, 5= hard
Eligibility Criteria
Criteria
Inclusion Criteria:
-
medical staff working at the Vienna General Hospital
-
oral and written consent to take part voluntarily in this trial
Exclusion Criteria:
-
hypersensitivity / allergy against Nonylvanillamid, Nikotinsäure-beta-butoxyethylester or other component of "Finalgon Salbe"
-
not Coronavirus disease-19 vaccinated
-
pregnancy
-
breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Vienna | Vienna | Austria |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Georg Röder, M.D., Medical University of Vienna, Dept. of Anaesthesiology, Critical Care and Pain Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Fletcher SJ, Clark M, Stanley PJ. Carbon dioxide re-breathing with close fitting face respirator masks. Anaesthesia. 2006 Sep;61(9):910.
- 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.
- Özdemir L, Azizoğlu M, Yapıcı 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.
- 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.
- 1144/2021