CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 231 enrolled
Drug / intervention
Resmon PRO FULLdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04140825
NCT04140825N/ACompleted

Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects

Restech Srl·observational·Posted Oct 28, 2019·Updated Jun 30, 2022

In Brief

An observational study evaluating Resmon PRO FULL for Respiratory Disease. Completed, enrolled 231 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly, United States
CollaboratorsMGC Diagnostics

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 28, 2019
Enrollment StartOct 18, 2018
Primary CompletionJun 28, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.7 years ago

Interventions

Resmon PRO FULLdevice

Measurement of lung impedance by the Forced Oscillation Technique