Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects
NCT ID: NCT04140825
Last Updated: 2022-06-30
Study Results
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Basic Information
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COMPLETED
231 participants
OBSERVATIONAL
2018-10-18
2022-06-28
Brief Summary
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The purpose of this study is to establish reference ranges for within breath FOT parameters and their short term variability.
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Detailed Description
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The purpose of this study is to establish reference ranges for within breath FOT parameters and their short term variability.
Objectives Primary: To derive equations to predict normal values and normality ranges for within-breath respiratory system resistance, reactance and related parameters at the selected stimulating waveform and to measure the short term variability of such parameters.
Secondary: To demonstrate the equivalence of the results of a single multiple-breath test to results obtained as an average of 3 consecutive repeated tests.
Study design This will be a prospective multi-center trial of healthy subjects. After signing the Informed Consent, an interview and physical examination will be performed. The examiner will confirm that subjects are able to perform acceptable and repeatable spirometry. FOT measurements will be performed, followed by standard spirometry measurements.
Study Duration This is a single visit study. Subject participation will be completed in 1 hour and 15 min. Enrollment of all subjects is expected to take 23 weeks (6 months).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Subjects\>=18 years old will measure as a minimum FOT and spirometry.
Resmon PRO FULL
Measurement of lung impedance by the Forced Oscillation Technique
Interventions
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Resmon PRO FULL
Measurement of lung impedance by the Forced Oscillation Technique
Eligibility Criteria
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Inclusion Criteria
* Signature of the written informed consent
Exclusion Criteria
* Abnormal spirometry defined as FEV1, FEV1/VC and VC below the LLN as established by the Global Lung function (GLI) 2012 reference equations.
* Smokers or ex-smokers
* BMI \>30 kg/cm2
* History of respiratory symptoms using the ECRHS II screening questionnaire (www.ecrhs.org)
* Wheezing
* Cough
* Phlegm production
* Dyspnea
* Feeling of chest tightness
* Night awakening due to a cough attack
* Have a history of pulmonary or cardiac disease
* Had a recent (e.g., in the last 4 weeks) respiratory tract infection
* Have a neurological or neuromuscular disorder
18 Years
ALL
Yes
Sponsors
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MGC Diagnostics
UNKNOWN
Restech Srl
INDUSTRY
Responsible Party
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Principal Investigators
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David Kaminsky, MD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont Medical Center Inc
Locations
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Biomedical Research Institute at Harbor- UCLA Medical Center
Los Angeles, California, United States
University of Vermont Medical Center Inc.
Burlington, Vermont, United States
Catholic University of the Sacred Heart
Rome, RM, Italy
U.O.C. Malattie dell'apparato respiratorio e endoscopia delle vie aeree - Ospedale San Giovanni
Roma, Rome, Italy
Countries
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References
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DUBOIS AB, BRODY AW, LEWIS DH, BURGESS BF Jr. Oscillation mechanics of lungs and chest in man. J Appl Physiol. 1956 May;8(6):587-94. doi: 10.1152/jappl.1956.8.6.587. No abstract available.
Peslin R, Ying Y, Gallina C, Duvivier C. Within-breath variations of forced oscillation resistance in healthy subjects. Eur Respir J. 1992 Jan;5(1):86-92.
Horowitz JG, Siegel SD, Primiano FP Jr, Chester EH. Computation of respiratory impedance from forced sinusoidal oscillations during breathing. Comput Biomed Res. 1983 Dec;16(6):499-521. doi: 10.1016/0010-4809(83)90037-x.
Dellaca RL, Santus P, Aliverti A, Stevenson N, Centanni S, Macklem PT, Pedotti A, Calverley PM. Detection of expiratory flow limitation in COPD using the forced oscillation technique. Eur Respir J. 2004 Feb;23(2):232-40. doi: 10.1183/09031936.04.00046804.
Dellaca RL, Pompilio PP, Walker PP, Duffy N, Pedotti A, Calverley PM. Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD. Eur Respir J. 2009 Jun;33(6):1329-37. doi: 10.1183/09031936.00139608. Epub 2009 Jan 22.
Pasker HG, Schepers R, Clement J, Van de Woestijne KP. Total respiratory impedance measured by means of the forced oscillation technique in subjects with and without respiratory complaints. Eur Respir J. 1996 Jan;9(1):131-9. doi: 10.1183/09031936.96.09010132.
Brown NJ, Xuan W, Salome CM, Berend N, Hunter ML, Musk AW, James AL, King GG. Reference equations for respiratory system resistance and reactance in adults. Respir Physiol Neurobiol. 2010 Jul 31;172(3):162-8. doi: 10.1016/j.resp.2010.05.013. Epub 2010 May 15.
Aarli BB, Eagan TM, Ellingsen I, Bakke PS, Hardie JA. Reference values for within-breath pulmonary impedance parameters in asymptomatic elderly. Clin Respir J. 2013 Jul;7(3):245-52. doi: 10.1111/j.1752-699X.2012.00312.x. Epub 2012 Aug 20.
Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.
Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
Calogero C, Simpson SJ, Lombardi E, Parri N, Cuomo B, Palumbo M, de Martino M, Shackleton C, Verheggen M, Gavidia T, Franklin PJ, Kusel MM, Park J, Sly PD, Hall GL. Respiratory impedance and bronchodilator responsiveness in healthy children aged 2-13 years. Pediatr Pulmonol. 2013 Jul;48(7):707-15. doi: 10.1002/ppul.22699. Epub 2012 Nov 20.
Ducharme FM, Davis GM, Ducharme GR. Pediatric reference values for respiratory resistance measured by forced oscillation. Chest. 1998 May;113(5):1322-8. doi: 10.1378/chest.113.5.1322.
Oostveen E, Boda K, van der Grinten CP, James AL, Young S, Nieland H, Hantos Z. Respiratory impedance in healthy subjects: baseline values and bronchodilator response. Eur Respir J. 2013 Dec;42(6):1513-23. doi: 10.1183/09031936.00126212. Epub 2013 Apr 18.
Knofczynski, G. T. & Mundfrom, D. Sample Sizes When Using Multiple Linear Regression for Prediction. Educ. Psychol. Meas. 68, 431-442 (2007).
Other Identifiers
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1/17 ADU
Identifier Type: -
Identifier Source: org_study_id
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