Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06053502
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2023-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respirator and Breathing Compartments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-24', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inspiratory time', 'timeFrame': 'up to 12 weeks', 'description': '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.'}, {'measure': 'Expiratory time', 'timeFrame': 'up to 12 weeks', 'description': '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.'}, {'measure': 'Chest wall compartments', 'timeFrame': 'up to 12 weeks', 'description': '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.'}, {'measure': 'Breathing frequency', 'timeFrame': 'up to 12 weeks', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['optoelectronic plethysmography', 'breathing compartments', 'N95', 'graded exercise test'], 'conditions': ['Face Mask Squeeze', 'Respiratory Complication']}, 'referencesModule': {'references': [{'pmid': '34126242', 'type': 'BACKGROUND', 'citation': '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': '15994253', 'type': 'BACKGROUND', 'citation': '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': '15578206', 'type': 'BACKGROUND', 'citation': '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': '35095185', 'type': 'BACKGROUND', 'citation': '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': '21683217', 'type': 'BACKGROUND', 'citation': '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': '2924519', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nProtocol:\n\nParticipants 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.\n\nOpto-Electronic Plethysmography:\n\nThe 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.\n\nThe 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.\n\nGraded Exercise Tests:\n\nTo 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Students of physical education and sport', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physically active (\\~260 min/week) possessing high fitness level,\n* free from injury,\n* able to give full written consent,\n* meet age criteria 19-26 years.\n\nExclusion Criteria:\n\n* smokers,\n* chronic pulmonary disease,\n* cardiac disease.'}, 'identificationModule': {'nctId': 'NCT06053502', 'acronym': 'Breathing', 'briefTitle': 'Respirator and Breathing Compartments', 'organization': {'class': 'OTHER', 'fullName': 'University of South Bohemia'}, 'officialTitle': 'The Filtering Facepiece Respirator Increases Inspiratory Time, But Does Not Change the Involvement of Breathing Compartments', 'orgStudyIdInfo': {'id': 'KPTVSPFJUAugust2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Masked condition', 'description': 'Participants who underwent the graded exercise test with the respirator.', 'interventionNames': ['Other: filtering facepiece respirator']}, {'label': 'Unmasked condition', 'description': 'Participants who underwent the graded exercise test without the respirator.'}], 'interventions': [{'name': 'filtering facepiece respirator', 'type': 'OTHER', 'description': 'Graded exercise test with filtering facepiece respirator', 'armGroupLabels': ['Masked condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37005', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'University of South Bohemia', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}], 'overallOfficials': [{'name': 'David Marko, Mgr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Bohemia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Bohemia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}