Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects

NCT04140825 | Completed FDA Device

• 1 other identifier: 1/17 ADU
• Study Type: observational
• Target: 231
• Locations: 2 countries
• Sites: 4

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.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• Correlation between respiratory impedance parameters and the following variables: age, height, weight, sex, abdominal circumference and phenotype, breathing pattern parameters.

  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

  1 day

Secondary Outcomes (1)

• Noninferiority of one FOT test vs. the average of three consecutive tests

  1 day

Study Arms (1)

Group 1

Subjects\>=18 years old will measure as a minimum FOT and spirometry.

Device: Resmon PRO FULL

Interventions

Resmon PRO FULL DEVICE

Measurement of lung impedance by the Forced Oscillation Technique

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The following group will be considered: Adults (\>= 18 years old)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Restech Srl: lead
• MGC Diagnostics: collaborator

Study Sites (4)

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

Catholic University of the Sacred Heart

Rome, RM, 00100, Italy

Location

U.O.C. Malattie dell'apparato respiratorio e endoscopia delle vie aeree - Ospedale San Giovanni

Roma, Rome, 00184, Italy

Location

Related Publications (16)

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  PMID: 19164347 BACKGROUND

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  PMID: 14680096 BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• David Kaminsky, MD

  University of Vermont Medical Center Inc

  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: October 28, 2019
• Study Start: October 18, 2018
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

IT (2); US (2)