Face Mask SqueezeBreathingNCT06053502
Respirator and Breathing Compartments
An observational study of Face Mask Squeeze and Respiratory Complication, run by University of South Bohemia at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Face Mask Squeeze, Respiratory Complication
- What is being tested?
- filtering facepiece respirator
- How many people
- 21 participants
- Where
- 1 siteCzechia
- Study dates
- 2 Jan 2023to 26 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Students of physical education and sport
Who may be able to join
- physically active (~260 min/week) possessing high fitness level,
- free from injury,
- able to give full written consent,
- meet age criteria 19-26 years.
Who cannot join
- smokers,
- chronic pulmonary disease,
- cardiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Face Mask Squeeze, Respiratory Complication
- Being tested
- filtering facepiece respirator
- Keywords
- optoelectronic plethysmography, breathing compartments, N95, graded exercise test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filtering facepiece respiratorOther
Graded exercise test with filtering facepiece respirator
| Study group | Role | What they receive |
|---|---|---|
| Masked condition | Participants who underwent the graded exercise test with the respirator. Receives: Other: filtering facepiece respirator | |
| Unmasked condition | Participants who underwent the graded exercise test without the respirator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory time
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.
Measured: up to 12 weeks
Expiratory time
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.
Measured: up to 12 weeks
Chest wall compartments
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.
Measured: up to 12 weeks
Breathing frequency
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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start2 Jan 2023
- Primary completion25 Mar 2023
- Study completion26 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Face Mask SqueezeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Bohemia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Marko, Mgr, Principal investigator, University of South Bohemia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053502
- Sponsor's protocol ID
- KPTVSPFJUAugust2023
- Acronym
- Breathing
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Au SCL. The model of N95 face mask used and hypercapnia proof upon choroidal thickness measurement. Photodiagnosis Photodyn Ther. 2021 Sep;35:102399. doi: 10.1016/j.pdpdt.2021.102399. Epub 2021 Jun 11. No abstract available.
PubMed 34126242Aliverti A, Rodger K, Dellaca RL, Stevenson N, Lo Mauro A, Pedotti A, Calverley PM. Effect of salbutamol on lung function and chest wall volumes at rest and during exercise in COPD. Thorax. 2005 Nov;60(11):916-24. doi: 10.1136/thx.2004.037937. Epub 2005 Jun 30.
PubMed 15994253Vogiatzis I, Aliverti A, Golemati S, Georgiadou O, Lomauro A, Kosmas E, Kastanakis E, Roussos C. Respiratory kinematics by optoelectronic plethysmography during exercise in men and women. Eur J Appl Physiol. 2005 Mar;93(5-6):581-7. doi: 10.1007/s00421-004-1249-4. Epub 2004 Dec 1.
PubMed 15578206Aliabadi M, Aghamiri ZS, Farhadian M, Shafiee Motlagh M, Hamidi Nahrani M. The Influence of Face Masks on Verbal Communication in Persian in the Presence of Background Noise in Healthcare Staff. Acoust Aust. 2022;50(1):127-137. doi: 10.1007/s40857-021-00260-3. Epub 2022 Jan 26.
PubMed 35095185Redlinger RE Jr, Kelly RE, Nuss D, Goretsky M, Kuhn MA, Sullivan K, Wootton AE, Ebel A, Obermeyer RJ. Regional chest wall motion dysfunction in patients with pectus excavatum demonstrated via optoelectronic plethysmography. J Pediatr Surg. 2011 Jun;46(6):1172-6. doi: 10.1016/j.jpedsurg.2011.03.047.
PubMed 21683217Wilson RC, Jones PW. A comparison of the visual analogue scale and modified Borg scale for the measurement of dyspnoea during exercise. Clin Sci (Lond). 1989 Mar;76(3):277-82. doi: 10.1042/cs0760277.
PubMed 2924519
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Filtering Facepiece Respirator Increases Inspiratory Time, But Does Not Change the Involvement of Breathing Compartments
- ClinicalTrials.gov ID
- NCT06053502
- Acronym / sponsor ID
- Breathing / KPTVSPFJUAugust2023
- Conditions
- Face Mask Squeeze, Respiratory Complication
- Keywords
- optoelectronic plethysmography, breathing compartments, N95, graded exercise test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of South BohemiaUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 26 Aug 2023 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Masked condition | – | Other: filtering facepiece respiratorParticipants who underwent the graded exercise test with the respirator. |
| Unmasked condition | – | –Participants who underwent the graded exercise test without the respirator. |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Students of physical education and sport
Key inclusion criteria (4 listed)
- physically active (~260 min/week) possessing high fitness level,
- free from injury,
- able to give full written consent,
- meet age criteria 19-26 years.
Key exclusion criteria (3 listed)
- smokers,
- chronic pulmonary disease,
- cardiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filtering facepiece respiratorGraded exercise test with filtering facepiece respirator | Other | Masked condition |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 34126242Au SCL. The model of N95 face mask used and hypercapnia proof upon choroidal thickness measurement. Photodiagnosis Photodyn Ther. 2021 Sep;35:102399. doi: 10.1016/j.pdpdt.2021.102399. Epub 2021 Jun 11. No abstract available.
- Background: PubMed 15994253Aliverti A, Rodger K, Dellaca RL, Stevenson N, Lo Mauro A, Pedotti A, Calverley PM. Effect of salbutamol on lung function and chest wall volumes at rest and during exercise in COPD. Thorax. 2005 Nov;60(11):916-24. doi: 10.1136/thx.2004.037937. Epub 2005 Jun 30.
- Background: PubMed 15578206Vogiatzis I, Aliverti A, Golemati S, Georgiadou O, Lomauro A, Kosmas E, Kastanakis E, Roussos C. Respiratory kinematics by optoelectronic plethysmography during exercise in men and women. Eur J Appl Physiol. 2005 Mar;93(5-6):581-7. doi: 10.1007/s00421-004-1249-4. Epub 2004 Dec 1.
- Background: PubMed 35095185Aliabadi M, Aghamiri ZS, Farhadian M, Shafiee Motlagh M, Hamidi Nahrani M. The Influence of Face Masks on Verbal Communication in Persian in the Presence of Background Noise in Healthcare Staff. Acoust Aust. 2022;50(1):127-137. doi: 10.1007/s40857-021-00260-3. Epub 2022 Jan 26.
- Background: PubMed 21683217Redlinger RE Jr, Kelly RE, Nuss D, Goretsky M, Kuhn MA, Sullivan K, Wootton AE, Ebel A, Obermeyer RJ. Regional chest wall motion dysfunction in patients with pectus excavatum demonstrated via optoelectronic plethysmography. J Pediatr Surg. 2011 Jun;46(6):1172-6. doi: 10.1016/j.jpedsurg.2011.03.047.
- Background: PubMed 2924519Wilson RC, Jones PW. A comparison of the visual analogue scale and modified Borg scale for the measurement of dyspnoea during exercise. Clin Sci (Lond). 1989 Mar;76(3):277-82. doi: 10.1042/cs0760277.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Marko, Mgr principal investigator
University of South Bohemia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Face Mask Squeeze and Respiratory Complication, run by University of South Bohemia at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory time (time frame: up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06053502, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.