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Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies

NCT04006964 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 579

Last updated 2022-11-03

No results posted yet for this study

Summary

The diagnosis of a lung function anomaly 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) measures lung impedance during tidal breathing, requiring minimal patient cooperation. The purpose of this study is to establish the diagnostic accuracy of FOT parameters alone or in combination with lung volumes in detecting lung function anomalies as compared with spirometry and with the diagnosis made by the physician.

Conditions

  • Respiratory Disease

Interventions

DEVICE

Resmon PRO FULL v2

Measurement of lung impedance by the Forced Oscillation Technique

Sponsors & Collaborators

  • MGC Diagnostics

    collaborator UNKNOWN

  • Restech Srl

    lead INDUSTRY

Principal Investigators

  • Riccardo Inchingolo, MD · Catholic University of the Sacred Heart

  • Stefania La Grutta, MD · Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"

  • Enrico Lombardi, MD · Meyer Children's Hospital IRCCS

  • David Kaminsky, MD · University of Vermont Medical Center Inc

  • Janos Porszasz, MD · Biomedical Research Institute at Harbor- UCLA Medical Center

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2022-06-26
Completion
2022-06-26
FDA Device
Yes

Countries

  • United States
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04006964 on ClinicalTrials.gov