Changes in Capillary Carbon Dioxide Partial Pressure (pCO2) While Wearing FFP2 / FFP3 Masks
Primary Purpose
Hypercapnia
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
No mask
Filtering face mask 2 (FFP2)
Filtering face mask 3 (FFP3)
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypercapnia
Eligibility 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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
FFP2
FFP3
Arm Description
This arm starts with a FFP2 mask and switches to a FFP3 mask.
This arm starts with a FFP3 mask and switches to a FFP2 mask.
Outcomes
Primary Outcome Measures
Change of PcCO2
Change of capillary carbon dioxide partial pressure (PcCO2)
Secondary Outcome Measures
Change of PcO2
Change of capillary oxygen partial pressure (PcO2)
Respiratory rate
Number of breaths per minute
Exertion score
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
Full Information
NCT ID
NCT04980820
First Posted
July 14, 2021
Last Updated
December 16, 2022
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04980820
Brief Title
Changes in Capillary Carbon Dioxide Partial Pressure (pCO2) While Wearing FFP2 / FFP3 Masks
Official Title
Changes in Capillary pCO2 While Wearing FFP2 and FFP3 Masks Masks by Medical Staff - a Prospective Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
arm: starts with no mask - FFP2 mask - FFP3 mask
arm: starts with no mask - FFP3 mask - FFP2 mask
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FFP2
Arm Type
Experimental
Arm Description
This arm starts with a FFP2 mask and switches to a FFP3 mask.
Arm Title
FFP3
Arm Type
Experimental
Arm Description
This arm starts with a FFP3 mask and switches to a FFP2 mask.
Intervention Type
Other
Intervention Name(s)
No mask
Intervention Description
The participant is asked to wear no mask for 10 minutes.
Intervention Type
Device
Intervention Name(s)
Filtering face mask 2 (FFP2)
Intervention Description
The participant is asked to wear a FFP2 mask for 1 hour during work.
Intervention Type
Device
Intervention Name(s)
Filtering face mask 3 (FFP3)
Intervention Description
The participant is asked to wear a FFP3 mask for 1 hour during work.
Primary Outcome Measure Information:
Title
Change of PcCO2
Description
Change of capillary carbon dioxide partial pressure (PcCO2)
Time Frame
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)
Secondary Outcome Measure Information:
Title
Change of PcO2
Description
Change of capillary oxygen partial pressure (PcO2)
Time Frame
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)
Title
Respiratory rate
Description
Number of breaths per minute
Time Frame
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)
Title
Exertion score
Description
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
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Röder, M.D.
Organizational Affiliation
Medical University of Vienna, Dept. of Anaesthesiology, Critical Care and Pain Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31971553
Citation
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.
Results Reference
background
PubMed Identifier
16922771
Citation
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.
Results Reference
background
PubMed Identifier
32473501
Citation
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.
Results Reference
background
PubMed Identifier
22944510
Citation
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.
Results Reference
background
Links:
URL
https://www.who.int/publications/i/item/rational-use-of-personal-protective-equipment-for-coronavirus-disease-(covid-19)-and-considerations-during-severe-shortages
Description
Rational use of personal protective equipment for coronavirus disease (COVID-19) and considerations during severe shortages
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Changes in Capillary Carbon Dioxide Partial Pressure (pCO2) While Wearing FFP2 / FFP3 Masks
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