Respirator and Breathing Compartments

NCT06053502 | Completed

• 1 other identifier: KPTVSPFJUAugust2023
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Face Mask Squeeze; Respiratory Complication

Keywords

optoelectronic plethysmography; breathing compartments; N95; graded exercise test

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  up to 12 weeks

Study Arms (2)

Masked condition

Participants who underwent the graded exercise test with the respirator.

Other: filtering facepiece respirator

Unmasked condition

Participants who underwent the graded exercise test without the respirator.

Interventions

filtering facepiece respirator OTHER

Graded exercise test with filtering facepiece respirator

Masked condition

Eligibility Criteria

• Age: 19 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Students of physical education and sport

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of South Bohemia: lead

Study Sites (1)

University of South Bohemia

České Budějovice, 37005, Czechia

Location

Related Publications (6)

• 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.

  PMID: 34126242 BACKGROUND

• Aliverti 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.

  PMID: 15994253 BACKGROUND

• Vogiatzis 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.

  PMID: 15578206 BACKGROUND

• Aliabadi 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.

  PMID: 35095185 BACKGROUND

• Redlinger 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.

  PMID: 21683217 BACKGROUND

• Wilson 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.

  PMID: 2924519 BACKGROUND

Study Officials

• David Marko, Mgr

  University of South Bohemia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 25, 2023
• Study Start: January 2, 2023
• Primary Completion: March 25, 2023
• Study Completion: August 26, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)