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

Not Applicable

Completed

• Conditions: Hypercapnia
• Interventions: Other: No mask; Device: Filtering face mask 2 (FFP2); Device: Filtering face mask 3 (FFP3)

• Registration Number: NCT04980820
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2021-07-14
• Study Start: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-28
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• medical staff working at the Vienna General Hospital
• oral and written consent to take part voluntarily in this trial

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Exclusion Criteria

• hypersensitivity / allergy against Nonylvanillamid, Nikotinsäure-beta-butoxyethylester or other component of "Finalgon Salbe"
• not Coronavirus disease-19 vaccinated
• pregnancy
• breastfeeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FFP2	Filtering face mask 3 (FFP3)	This arm starts with a FFP2 mask and switches to a FFP3 mask.
FFP2	No mask	This arm starts with a FFP2 mask and switches to a FFP3 mask.
FFP2	Filtering face mask 2 (FFP2)	This arm starts with a FFP2 mask and switches to a FFP3 mask.
FFP3	No mask	This arm starts with a FFP3 mask and switches to a FFP2 mask.
FFP3	Filtering face mask 2 (FFP2)	This arm starts with a FFP3 mask and switches to a FFP2 mask.
FFP3	Filtering face mask 3 (FFP3)	This arm starts with a FFP3 mask and switches to a FFP2 mask.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria