Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies

NCT04006964 | Completed FDA Device

• 1 other identifier: 2/17
• Study Type: observational
• Target: 579
• Locations: 2 countries
• Sites: 6

Brief Summary

The diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing, requiring minimal patient cooperation. The purpose of this study is to establish the diagnostic accuracy of FOT parameters alone or in combination with lung volumes in detecting lung function anomalies as compared with spirometry and with the diagnosis made by the physician.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• Decision rule that maximises sensitivity and specificity as compared with spirometry

  This will be a rule to detect lung anomalies as compared with spirometry that will be identified and validated in two separate populations

  1 day

Secondary Outcomes (1)

• Decision rule that maximises sensitivity and specificity as compared with physician's diagnosis

  1 day

Study Arms (2)

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.

Device: Resmon PRO FULL v2

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.

Device: Resmon PRO FULL v2

Interventions

Resmon PRO FULL v2 DEVICE

Measurement of lung impedance by the Forced Oscillation Technique

Identification Group; Validation Group

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The following age groups will be considered: * Preschool children (3-5 years old) * School-age children (6-11 years old) * Adolescents (12-17 years old) * Adults (\>= 18 years old)

You may qualify if:

• All subjects ≥3 years old attending the pulmonary function laboratory with an order for PFT or

You may not qualify if:

• \- Subjects unable to provide written Informed Consent (or not provided by the participant's parent/guardian) and Assent Form (where applicable).

Sponsors & Collaborators

• Restech Srl: lead
• MGC Diagnostics: collaborator

Study Sites (6)

Biomedical Research Institute at Harbor- UCLA Medical Center

Los Angeles, California, 90502, United States

Location

University of Vermont Medical Center Inc.,

Burlington, Vermont, 05401, United States

Location

Azienda Ospedaliero, Universitaria Meyer

Florence, FI, 50139, Italy

Location

Catholic University of the Sacred Heart

Rome, Lazio, 00100, Italy

Location

ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"

Palermo, 90146, Italy

Location

Related Publications (17)

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  PMID: 16264058 BACKGROUND

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  PMID: 15994402 BACKGROUND

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  PMID: 15028561 BACKGROUND

• 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.

  PMID: 27168432 BACKGROUND

• 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.

  PMID: 3622024 BACKGROUND

• 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.

  PMID: 7606989 BACKGROUND

• 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.

  PMID: 21340218 BACKGROUND

• 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.

  PMID: 14979497 BACKGROUND

• 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.

  PMID: 25803710 BACKGROUND

• 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.

  PMID: 1577156 BACKGROUND

• 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.

  PMID: 19164347 BACKGROUND

• 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.

  PMID: 22743675 BACKGROUND

• 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.

  PMID: 17545458 BACKGROUND

• 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.

  PMID: 16135736 BACKGROUND

• 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.

  PMID: 23949369 BACKGROUND

• 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.

  PMID: 26510957 BACKGROUND

• 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.

  PMID: 26061787 BACKGROUND

Related Links

• Global Initiative for Asthma. Global strategy for asthma management and prevention, 2017.

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Riccardo Inchingolo, MD

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

• Stefania La Grutta, MD

  Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"

  PRINCIPAL INVESTIGATOR

• Enrico Lombardi, MD

  Meyer Children's Hospital IRCCS

  PRINCIPAL INVESTIGATOR

• David Kaminsky, MD

  University of Vermont Medical Center Inc

  PRINCIPAL INVESTIGATOR

• Janos Porszasz, MD

  Biomedical Research Institute at Harbor- UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 5, 2019
• Study Start: October 18, 2018
• Primary Completion: June 26, 2022
• Study Completion: June 26, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

IT (4); US (2)