Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects

Completed

Conditions studied: Respiratory Disease

In brief

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.

Key facts

Study ID

NCT04140825

Run by

Restech Srl

People needed

231

Starts

2018-10-18

Expected to finish

2022-06-28

Last updated by the study team

2022-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Biomedical Research Institute at Harbor- UCLA Medical Center — Los Angeles, California, United States
• University of Vermont Medical Center Inc. — Burlington, Vermont, United States
• Catholic University of the Sacred Heart — Rome, RM, Italy
• U.O.C. Malattie dell'apparato respiratorio e endoscopia delle vie aeree - Ospedale San Giovanni — Roma, Rome, Italy

Full record on ClinicalTrials.gov

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