NCT04980820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

July 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

July 14, 2021

Last Update Submit

December 16, 2022

Conditions

Hypercapnia

Outcome Measures

Primary Outcomes (1)

  • Change of PcCO2

    Change of capillary carbon dioxide partial pressure (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)

Secondary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (2)

FFP2

EXPERIMENTAL

This arm starts with a FFP2 mask and switches to a FFP3 mask.

Other: No maskDevice: Filtering face mask 2 (FFP2)Device: Filtering face mask 3 (FFP3)

FFP3

EXPERIMENTAL

This arm starts with a FFP3 mask and switches to a FFP2 mask.

Other: No maskDevice: Filtering face mask 2 (FFP2)Device: Filtering face mask 3 (FFP3)

Interventions

No maskOTHER

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

FFP2FFP3
Filtering face mask 2 (FFP2)DEVICE

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

FFP2FFP3
Filtering face mask 3 (FFP3)DEVICE

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

FFP2FFP3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

Related Publications (4)

  • 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.

    PMID: 31971553BACKGROUND

  • 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.

    PMID: 16922771BACKGROUND

  • 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.

    PMID: 32473501BACKGROUND

  • 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.

    PMID: 22944510BACKGROUND

Related Links

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Georg Röder, M.D.

    Medical University of Vienna, Dept. of Anaesthesiology, Critical Care and Pain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: 1. arm: starts with no mask - FFP2 mask - FFP3 mask 2. arm: starts with no mask - FFP3 mask - FFP2 mask
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr. David Baron, EDIC

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 28, 2021

Study Start

July 19, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

December 19, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)