Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies
NCT ID: NCT04006964
Last Updated: 2022-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
579 participants
OBSERVATIONAL
2018-10-18
2022-06-26
Brief Summary
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Detailed Description
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Objectives Primary: To compare the diagnostic accuracy of FOT with spirometry to detect a lung function anomaly (i.e. an obstructive and/or restrictive respiratory disease).
Secondary: To compare the diagnostic accuracy of FOT with the final diagnosis made by the physician (i.e. the diagnosis based on current guidelines) to detect a lung function anomaly (i.e. an obstructive and/or restrictive respiratory disease).
Study Design This will be a multi-center prospective study of consecutive subjects attending the pulmonary function test laboratory for pulmonary function tests (PFT) or randomly taken from the clinical site's records among those with symptoms with two separate study phases, an Identification Phase and a Validation Phase. Subjects will undergo the same study procedures in both phases. After signing the Informed Consent, a medical history will be obtained, a physical examination performed, and PFT (FOT, spirometry and, if required by the physician to reach a final diagnosis, additional lung function measurements) will be performed.
Identification Phase: Subject data will be used to identify two separate rules based on abnormal lung volumes and impedance (FOT) parameters that will maximize the accuracy in identifying a lung function anomaly. For the primary objective, the reference test for the determination of such lung anomaly will be spirometry. For the secondary objective, the reference test for the determination of the presence of a lung function anomaly will be the final diagnosis made by the physician.
Validation Phase: A separate and independent dataset of subjects will be used to test the accuracy of the rules identified from analysis of the Identification Phase in detecting a lung function anomaly.
Study Duration Subject participation will be completed in 1 day. Study duration is expected to be 7 months
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Identification Group
Subjects \>= 3 years old will measure as a minimum FOT and spirometry. Final diagnosis will be made by the physician as per current guidelines.
Resmon PRO FULL v2
Measurement of lung impedance by the Forced Oscillation Technique
Validation Group
Subjects \>= 3 years old will measure as a minimum FOT and spirometry. Final diagnosis will be made by the physician as per current guidelines.
Resmon PRO FULL v2
Measurement of lung impedance by the Forced Oscillation Technique
Interventions
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Resmon PRO FULL v2
Measurement of lung impedance by the Forced Oscillation Technique
Eligibility Criteria
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Inclusion Criteria
* Subjects ≥3 years old randomly chosen from a database of subjects having respiratory symptoms at the time of inclusion into the database.
Exclusion Criteria
3 Years
ALL
No
Sponsors
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MGC Diagnostics
UNKNOWN
Restech Srl
INDUSTRY
Responsible Party
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Principal Investigators
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Riccardo Inchingolo, MD
Role: PRINCIPAL_INVESTIGATOR
Catholic University of the Sacred Heart
Stefania La Grutta, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"
Enrico Lombardi, MD
Role: PRINCIPAL_INVESTIGATOR
Meyer Children's Hospital IRCCS
David Kaminsky, MD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont Medical Center Inc
Janos Porszasz, MD
Role: PRINCIPAL_INVESTIGATOR
Biomedical Research Institute at Harbor- UCLA Medical Center
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
Azienda Ospedaliero, Universitaria Meyer
Florence, FI, Italy
Catholic University of the Sacred Heart
Rome, Lazio, Italy
ASST Papa Giovanni XXIII
Bergamo, , Italy
Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"
Palermo, , Italy
Countries
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References
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Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, 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. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
Aurora P, Stocks J, Oliver C, Saunders C, Castle R, Chaziparasidis G, Bush A; London Cystic Fibrosis Collaboration. Quality control for spirometry in preschool children with and without lung disease. Am J Respir Crit Care Med. 2004 May 15;169(10):1152-9. doi: 10.1164/rccm.200310-1453OC. Epub 2004 Mar 17.
Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, Gouskova NA, Hansel NN, Hoffman EA, Kanner RE, Kleerup E, Lazarus SC, Martinez FJ, Paine R 3rd, Rennard S, Tashkin DP, Han MK; SPIROMICS Research Group. Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med. 2016 May 12;374(19):1811-21. doi: 10.1056/NEJMoa1505971.
van Noord JA, Wellens W, Clarysse I, Cauberghs M, Van de Woestijne KP, Demedts M. Total respiratory resistance and reactance in patients with upper airway obstruction. Chest. 1987 Sep;92(3):475-80. doi: 10.1378/chest.92.3.475.
Zerah F, Lorino AM, Lorino H, Harf A, Macquin-Mavier I. Forced oscillation technique vs spirometry to assess bronchodilatation in patients with asthma and COPD. Chest. 1995 Jul;108(1):41-7. doi: 10.1378/chest.108.1.41.
Faria AC, Costa AA, Lopes AJ, Jansen JM, Melo PL. Forced oscillation technique in the detection of smoking-induced respiratory alterations: diagnostic accuracy and comparison with spirometry. Clinics (Sao Paulo). 2010;65(12):1295-304. doi: 10.1590/s1807-59322010001200012.
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, Aliverti A, Lo Mauro A, Lutchen KR, Pedotti A, Suki B. Correlated variability in the breathing pattern and end-expiratory lung volumes in conscious humans. PLoS One. 2015 Mar 24;10(3):e0116317. doi: 10.1371/journal.pone.0116317. eCollection 2015.
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.
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.
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.
Beydon N, Davis SD, Lombardi E, Allen JL, Arets HG, Aurora P, Bisgaard H, Davis GM, Ducharme FM, Eigen H, Gappa M, Gaultier C, Gustafsson PM, Hall GL, Hantos Z, Healy MJ, Jones MH, Klug B, Lodrup Carlsen KC, McKenzie SA, Marchal F, Mayer OH, Merkus PJ, Morris MG, Oostveen E, Pillow JJ, Seddon PC, Silverman M, Sly PD, Stocks J, Tepper RS, Vilozni D, Wilson NM; American Thoracic Society/European Respiratory Society Working Group on Infant and Young Children Pulmonary Function Testing. An official American Thoracic Society/European Respiratory Society statement: pulmonary function testing in preschool children. Am J Respir Crit Care Med. 2007 Jun 15;175(12):1304-45. doi: 10.1164/rccm.200605-642ST. 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.
Brazzale DJ, Hall GL, Pretto JJ. Effects of adopting the new global lung function initiative 2012 reference equations on the interpretation of spirometry. Respiration. 2013;86(3):183-9. doi: 10.1159/000352046. Epub 2013 Aug 14.
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies. Clin Chem. 2015 Dec;61(12):1446-52. doi: 10.1373/clinchem.2015.246280. Epub 2015 Oct 28.
Senn S. Review of Fleiss, statistical methods for rates and proportions. Res Synth Methods. 2011 Sep;2(3):221-2. doi: 10.1002/jrsm.50. Epub 2011 Dec 14. No abstract available.
Related Links
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Global Initiative for Asthma. Global strategy for asthma management and prevention, 2017.
Other Identifiers
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2/17
Identifier Type: -
Identifier Source: org_study_id
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