Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies

November 2, 2022 updated by: Restech Srl
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose and Rationale 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. FOT measures lung impedance during tidal breathing, requiring minimal patient cooperation. 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 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.

Objectives Primary: To compare the diagnostic accuracy of FOT with spirometry to detect a lung function anomaly (i.e. an obstructive and/or restrictive respiratory disease).

Secondary: To compare the diagnostic accuracy of FOT with the final diagnosis made by the physician (i.e. the diagnosis based on current guidelines) to detect a lung function anomaly (i.e. an obstructive and/or restrictive respiratory disease).

Study Design This will be a multi-center prospective study of consecutive subjects attending the pulmonary function test laboratory for pulmonary function tests (PFT) or randomly taken from the clinical site's records among those with symptoms with two separate study phases, an Identification Phase and a Validation Phase. Subjects will undergo the same study procedures in both phases. After signing the Informed Consent, a medical history will be obtained, a physical examination performed, and PFT (FOT, spirometry and, if required by the physician to reach a final diagnosis, additional lung function measurements) will be performed.

Identification Phase: Subject data will be used to identify two separate rules based on abnormal lung volumes and impedance (FOT) parameters that will maximize the accuracy in identifying a lung function anomaly. For the primary objective, the reference test for the determination of such lung anomaly will be spirometry. For the secondary objective, the reference test for the determination of the presence of a lung function anomaly will be the final diagnosis made by the physician.

Validation Phase: A separate and independent dataset of subjects will be used to test the accuracy of the rules identified from analysis of the Identification Phase in detecting a lung function anomaly.

Study Duration Subject participation will be completed in 1 day. Study duration is expected to be 7 months

Study Type

Observational

Enrollment (Actual)

579

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • ASST Papa Giovanni XXIII
      • Palermo, Italy, 90146
        • Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"
    • FI
      • Firenze, FI, Italy, 50139
        • Azienda Ospedaliero, Universitaria Meyer
    • Lazio
      • Roma, Lazio, Italy, 00100
        • Catholic University of the Sacred Heart
  • United States
    • California
      • Los Angeles, California, United States, 90502
        • Biomedical Research Institute at Harbor- UCLA Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center Inc.,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The following age groups will be considered:

  • Preschool children (3-5 years old)
  • School-age children (6-11 years old)
  • Adolescents (12-17 years old)
  • Adults (>= 18 years old)

Description

Inclusion Criteria:

  • All subjects ≥3 years old attending the pulmonary function laboratory with an order for PFT or
  • Subjects ≥3 years old randomly chosen from a database of subjects having respiratory symptoms at the time of inclusion into the database.

Exclusion Criteria:

- Subjects unable to provide written Informed Consent (or not provided by the participant's parent/guardian) and Assent Form (where applicable).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Identification Group
Subjects >= 3 years old will measure as a minimum FOT and spirometry. Final diagnosis will be made by the physician as per current guidelines.
Device: Resmon PRO FULL v2
Measurement of lung impedance by the Forced Oscillation Technique
Validation Group
Subjects >= 3 years old will measure as a minimum FOT and spirometry. Final diagnosis will be made by the physician as per current guidelines.
Device: Resmon PRO FULL v2
Measurement of lung impedance by the Forced Oscillation Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision rule that maximises sensitivity and specificity as compared with spirometry
Time Frame: 1 day
This will be a rule to detect lung anomalies as compared with spirometry that will be identified and validated in two separate populations
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision rule that maximises sensitivity and specificity as compared with physician's diagnosis
Time Frame: 1 day
This will be a rule to detect lung anomalies as compared with physician's final diagnosis that will be identified and validated in two separate populations
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restech Srl

Collaborators

MGC Diagnostics

Investigators

  • Principal Investigator: Riccardo Inchingolo, MD, Catholic University of the Sacred Heart
  • Principal Investigator: Stefania La Grutta, MD, Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"
  • Principal Investigator: Enrico Lombardi, MD, Azienda Ospedaliero, Universitaria Meyer
  • Principal Investigator: David Kaminsky, MD, University of Vermont Medical Center Inc
  • Principal Investigator: Janos Porszasz, MD, Biomedical Research Institute at Harbor- UCLA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2018

Primary Completion (Actual)

June 26, 2022

Study Completion (Actual)

June 26, 2022

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/17

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Disease

Clinical Trials on Resmon PRO FULL v2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe