Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects

Completed

• Conditions: Respiratory Disease
• Interventions: Device: Resmon PRO FULL

• Registration Number: NCT04140825
• Lead Sponsor: Restech Srl

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.

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 Timeline

• Study Start: 2018-10-18
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-28
• Status Verified: 2022-06
• Primary Completion: 2022-06-28
• Study Completion: 2022-06-28
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Resmon PRO FULL	Subjects\>=18 years old will measure as a minimum FOT and spirometry.

Primary Outcome Measures

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

Name	Time	Method
Noninferiority of one FOT test vs. the average of three consecutive tests	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

Trial Locations

Locations (4)

Biomedical Research Institute at Harbor- UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

University of Vermont Medical Center Inc.; 🇺🇸 Burlington, Vermont, United States

U.O.C. Malattie dell'apparato respiratorio e endoscopia delle vie aeree - Ospedale San Giovanni; 🇮🇹 Roma, Rome, Italy

Catholic University of the Sacred Heart; 🇮🇹 Rome, RM, Italy