Respirator and Breathing Compartments (Breathing)

September 24, 2023 updated by: University of South Bohemia

The Filtering Facepiece Respirator Increases Inspiratory Time, But Does Not Change the Involvement of Breathing Compartments

The purpose of this study was to compare breathing pattern and involvement of individual breathing compartments (IBC) with and without filtering facepiece respirator (FFR) during rest and exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study involved 21 students majoring in physical education and sports. All subjects were physically active, engaging in approximately 260 minutes of physical activity per week, and they possessed a high level of fitness. Inclusion criteria required participants to be free from injury, capable of providing written consent, and within the age range of 19 to 26 years. Exclusion criteria included individuals who smoked or had chronic pulmonary or cardiac diseases. This research received approval from the Ethics Committee at the Faculty of Education, University of South Bohemia, Reference Number: 002/2018. All procedures conducted within the study adhered to the ethical standards outlined by the Institutional Research Committee and the principles of the Helsinki Declaration.

Protocol:

Participants were instructed to visit the laboratory on two occasions to complete two separate tests during each session, specifically the Opto-electronic plethysmography (OEP) test during resting in a standing position and the OEP test during a Graded Exercise Test (GXT). The time interval between the testing days was three days. Participants were randomly assigned to two groups using randomizer.org. The first group performed three tests while wearing a Face-Fit Respirator (FFR), while the second group performed the tests without the mask. During the second visit, participants switched to the opposite condition. The N95 respirator was employed in this study as the gold standard for protection against aerosol transmission, particularly during the COVID-19 pandemic. A new mask was used for each test. In the Standing Test (STD), participants were instructed to maintain a stationary standing position and engage in spontaneous, quiet breathing without speaking or altering their posture while OEP data was collected. The first two minutes were designated as an adaptation period, followed by data collection for an additional three minutes. In the context of the Graded Exercise Test (GXT), OEP data was collected during the final minute of each three-minute stage.

Opto-Electronic Plethysmography:

The analysis of breathing patterns and volumes of chest wall compartments was conducted using opto-electronic plethysmography (BTS Bioengineering, Milan, Italy). This device comprises eight cameras, with five positioned anteriorly and three posteriorly relative to the participant. Additionally, 89 reflective markers were affixed to the participant's chest, abdomen, and back to track movements of the trunk. This technique has previously demonstrated validity in both resting and maximal exercise conditions.

The contributions of each breathing compartment (VRCp - pulmonary rib cage, VRCa - abdominal rib cage, VAb - abdomen) were determined by calculating the difference between end-inspiratory and end-expiratory volumes. The specific methodology for calculating chest wall kinematics using OEP has been detailed in prior research.

Graded Exercise Tests:

To complete this study, participants were required to undergo two maximal graded exercise tests (GXT) on separate days, one with the use of a Face-Fit Respirator (FFR) and one without. After three minutes of warm-up walking (2.7 km/h, 10% incline), participants performed the Bruce Protocol until exhaustion. The Bruce Protocol was conducted on a treadmill (Lode Valiant 2 Sport, Lode B.V., Groningen, Netherlands). All tests were conducted at the same time of day to mitigate the influence of circadian rhythms. Immediately following the completion of the test, participants provided ratings on the Modified Borg Dyspnea Scale, which ranges from 0 to 10, to assess breathlessness.

Study Type

Observational

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • České Budějovice, Czechia, 37005
        • University of South Bohemia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Students of physical education and sport

Description

Inclusion Criteria:

  • physically active (~260 min/week) possessing high fitness level,
  • free from injury,
  • able to give full written consent,
  • meet age criteria 19-26 years.

Exclusion Criteria:

  • smokers,
  • chronic pulmonary disease,
  • cardiac disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Masked condition
Participants who underwent the graded exercise test with the respirator.
Other: filtering facepiece respirator
Graded exercise test with filtering facepiece respirator
Unmasked condition
Participants who underwent the graded exercise test without the respirator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspiratory time
Time Frame: up to 12 weeks
Inspiratory time in every phase of the GXT will be presented as a mean and standard deviation, along with the mean difference and a 95% confidence interval of the difference. Inspiratory time will be measured using opto-electronic plethysmography, with units in [s], and the outcomes will be compared using a repeated-measures ANOVA with intra-subject comparisons.
up to 12 weeks
Expiratory time
Time Frame: up to 12 weeks
Expiratory time in every phase of the GXT will be presented as a mean and standard deviation, along with the mean difference and a 95% confidence interval of the difference. Expiratory time will be measured using opto-electronic plethysmography, with units in [s], and the outcomes will be compared using a repeated-measures ANOVA with intra-subject comparisons.
up to 12 weeks
Chest wall compartments
Time Frame: up to 12 weeks
The individual contribution of chest wall compartments in every phase of the GXT will be presented as a mean and standard deviation, along with the mean difference and a 95% confidence interval for the difference. Chest wall compartments will be measured using opto-electronic plethysmography, with units in [%VT - Tidal volume], and the outcomes will be compared using a repeated-measures ANOVA with intra-subject comparisons.
up to 12 weeks
Breathing frequency
Time Frame: up to 12 weeks
Breathing frequency in each phase of the GXT will be presented as a mean and standard deviation, along with the mean difference and a 95% confidence interval for the difference. Breathing frequency will be measured using opto-electronic plethysmography, with units in [bpm], and the outcomes will be compared using a repeated-measures ANOVA with intra-subject comparisons.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Bohemia

Investigators

  • Principal Investigator: David Marko, Mgr, University of South Bohemia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Actual)

March 25, 2023

Study Completion (Actual)

August 26, 2023

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KPTVSPFJUAugust2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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