Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04006964
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2019-06-27
Brief Title:
Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies
Sponsor:
Restech Srl
Organization:
Restech Srl
Study Overview
Official Title:
Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry However some patients eg 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
Detailed Description:
Purpose and Rationale The diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry However some patients eg 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 ie an obstructive andor restrictive respiratory disease
Secondary To compare the diagnostic accuracy of FOT with the final diagnosis made by the physician ie the diagnosis based on current guidelines to detect a lung function anomaly ie an obstructive andor 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 sites 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
Objectives Primary To compare the diagnostic accuracy of FOT with spirometry to detect a lung function anomaly ie an obstructive andor restrictive respiratory disease
Secondary To compare the diagnostic accuracy of FOT with the final diagnosis made by the physician ie the diagnosis based on current guidelines to detect a lung function anomaly ie an obstructive andor 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 sites 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None