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Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT04140825
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
MGC Diagnostics
Information provided by (Responsible Party):
Restech Srl

Study Description
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Brief Summary:

Assessment of lung function 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) is increasingly being used in clinical settings to evaluate lung function noninvasively by measuring the mechanical input impedance of the respiratory system. FOT measures lung impedance during tidal breathing, requiring minimal patient cooperation. Recently a new methodology (within breath analysis) has emerged to evaluate changes that occur in the impedance during the breathing activity. The within-breath calculation of impedance allows separating the contribution of inspiration and expiration to the measured parameters.

The purpose of this study is to establish reference ranges for within breath FOT parameters and their short term variability.


Condition or disease Intervention/treatment
Respiratory Disease Device: Resmon PRO FULL

Detailed Description:

Purpose and rationale Assessment of lung function 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) is increasingly being used in clinical settings to evaluate lung function noninvasively by measuring the mechanical input impedance of the respiratory system. FOT measures lung impedance during tidal breathing, requiring minimal patient cooperation. Recently a new methodology (within breath analysis) has emerged to evaluate changes that occur in the impedance during the breathing activity. The within-breath calculation of impedance allows separating the contribution of inspiration and expiration to the measured parameters.

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).

Study Design
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Study Type : Observational
Estimated Enrollment : 326 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1
Subjects>=18 years old will measure as a minimum FOT and spirometry.
 Device: Resmon PRO FULL
Measurement of lung impedance by the Forced Oscillation Technique


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between respiratory impedance parameters and the following variables: age, height, weight, sex, abdominal circumference and phenotype, breathing pattern parameters. [ Time Frame: 1 day ]
    The equation resulting from the multivariate regression analysis between impedance parameters assessed during the test and anthropometric measurements of age, height, weight, sex, abdominal circumference and phenotype, breathing pattern parameters


Secondary Outcome Measures :
  1. Noninferiority of one FOT test vs. the average of three consecutive tests [ Time Frame: 1 day ]
    Noninferiority hypothesis of the results of a single test with multiple breaths free from artifacts compared to those obtained in the same session as an average or 3 consecutive repeated tests


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The following group will be considered:

Adults (>= 18 years old)

Criteria

Inclusion Criteria:

  • Subjects ≥ 18 years of age.
  • Signature of the written informed consent

Exclusion Criteria:

Subjects will be excluded if they meet at least one of the following conditions:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140825


Contacts
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Contact: Alessandro Gobbi +390236593690 a.gobbi@restech.it
Contact: Pasquale Pompilio +390236593690 p.pompilio@restech.it

Locations
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United States, California
Biomedical Research Institute at Harbor- UCLA Medical Center Recruiting
Los Angeles, California, United States, 90502
Contact: Janos Porszasz, MD       porszasz@ucla.edu   
United States, Vermont
University of Vermont Medical Center Inc. Recruiting
Burlington, Vermont, United States, 05401
Contact: David Alan Kaminsky, MD       david.kaminsky@med.uvm.edu   
Italy
Catholic University of the Sacred Heart Recruiting
Rome, RM, Italy, 00100
Contact: Leonello Fuso, MD       leonello.fuso@policlinicogemelli.it   
Contact: Chiara Contu, MD    3487398380    chiara.contu@policlinicogemelli.it   
Ospedale Papa Giovanni XXIII Recruiting
Bergamo, Italy
Contact: Fabiano Di Marco         
Principal Investigator: Fabiano Di Marco         
Sub-Investigator: Gianluca Imeri         
Spain
Hospital Clínic de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Felipe Burgos Ricon, MD       FBURGOS@clinic.cat   
Sponsors and Collaborators
Restech Srl
MGC Diagnostics
Investigators
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Principal Investigator: Leonello Fuso, MD Catholic University of the Sacred Heart
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: Felip Burgos Rincón, MD Hospital Clínic de Barcelona
Principal Investigator: Fabiano Di Marco, MD Ospedale Papa Giovanni XXIII
More Information
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Publications:
Knofczynski, G. T. & Mundfrom, D. Sample Sizes When Using Multiple Linear Regression for Prediction. Educ. Psychol. Meas. 68, 431-442 (2007).

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Responsible Party: Restech Srl
ClinicalTrials.gov Identifier: NCT04140825    
Other Study ID Numbers: 1/17 ADU
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases