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OpenTrials
Completed

NCT Number: NCT04980820

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Mask

Other

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

Filtering face mask 2 (FFP2)

Device

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

Filtering face mask 3 (FFP3)

Device

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

Primary outcomes

  1. Change of 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)

    Change of capillary carbon dioxide partial pressure (PcCO2)

Secondary outcomes

  1. Change of 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)

    Change of capillary oxygen partial pressure (PcO2)

  2. Respiratory rate

    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)

    Number of breaths per minute

  3. Exertion score

    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)

    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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2021
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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