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Changes in Capillary Carbon Dioxide Partial Pressure (pCO2) While Wearing FFP2 / FFP3 Masks

Changes in Capillary pCO2 While Wearing FFP2 and FFP3 Masks Masks by Medical Staff - a Prospective Cross-over Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04980820
Enrollment
200
Registered
2021-07-28
Start date
2021-07-19
Completion date
2022-02-28
Last updated
2022-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnia

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.

Interventions

OTHERNo mask

The participant is asked to wear no mask for 10 minutes.

DEVICEFiltering face mask 2 (FFP2)

The participant is asked to wear a FFP2 mask for 1 hour during work.

DEVICEFiltering face mask 3 (FFP3)

The participant is asked to wear a FFP3 mask for 1 hour during work.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

1. arm: starts with no mask - FFP2 mask - FFP3 mask 2. arm: starts with no mask - FFP3 mask - FFP2 mask

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of PcCO21. 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

MeasureTime frameDescription
Change of PcO21. 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 rate1. 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 score1. 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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026