ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution (TOUPIE)
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|ClinicalTrials.gov Identifier: NCT03944928|
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : July 8, 2019
Idiopathic pulmonary fibrosis (IPF) is one of the most common chronic idiopathic fibrotic interstitial lung disease (ILD). IPF is an evolving disease that requires regular follow-up through clinical examination, respiratory functional investigations and thoracic CT. Thoracic CT is necessary for the follow-up, usually performed yearly, and in case of deterioration of respiratory function. The disadvantages to its realization are the repeated irradiation, the cost, the accessibility, and sometimes the difficulties of realization related to the supine position.
Several signs of thoracic ultrasound have been described in ILD, including the number of B lines, the irregularity of the pleural line, and the thickening of the pleural line. Cross-sectional studies have correlated the intensity of these signs with the severity of fibrosis lesions on chest CT in patients with ILD, including IPF. However, no studies have prospectively described the evolution of ultrasound signs in the same IPF patient, or their correlation to clinical, functional and CT scan evolution.
The hypothesis is that thoracic ultrasound is a relevant tool to highlight the evolution of pulmonary lesions in IPF.
The main objective is to show with thoracic ultrasound an increase in one or more of the ultrasound signs: line B score, pleural line irregularity score, and pleural line thickness during the follow-up of patient with IPF.
The study will enroll patients with a validated diagnosis of IPF in a multidisciplinary staff. At each follow-up visit, patients will have a clinical examination, pulmonary functional test and thoracic ultrasound. The CT data collected will include the last thoracic CT performed in the 3 months before the inclusion and those performed during the patient's participation. The presence, location and severity of ultrasound signs, will be recorded for each patient during successive reassessments and correlation to clinical, functional and CT scan evolution will be made.
This study will add significant knowledge in the study of ultrasound signs evolution in patients with IPF. If there is a correlation with the clinical or CT scores, it will be possible to carry over the realization of the CTs to limit the irradiation of the patients. Conversely, early detection of worsening ultrasound signs may lead to faster therapeutic adjustments to limit the extent of irreversible fibrotic lesions.
|Condition or disease||Intervention/treatment|
|Idiopathic Pulmonary Fibrosis||Other: Lung ultrasound|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution|
|Actual Study Start Date :||June 11, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
- Other: Lung ultrasound
For each usual consultation every 3 months, the patient will have clinical examination and pulmonary function tests (CPI score). Thoracic ultrasound will be made during the consultation (M0, M3, M6, M9 and M12). The presence, gravity and localisation of each ultrasound sign will be described. CT-scan data will be collected in the 3 months before the start of the study and during the study. To be enrolled in the study does not change to the usual follow-up.
For the thoracic ultrasound, a convex probe will be used (1 to 5 MHz). Patient will be layed down in a right lateral prone position then left. Thoracic ultrasound will be timed, saved and anonymized. 14 intercostal spaces will be explored by experimented operator.
The records will be seen a second time by same operator then a second operator. this will measured interoperator and intraoperator variability.
- Change of the B-line score from inclusion to 12 months [ Time Frame: Inclusion, 12 months ]number of line
- Change of pleural line irregularity from inclusion to 12 months [ Time Frame: Inclusion, 12 months ]Percentage
- Change of pleural line thickness from inclusion to 12 months [ Time Frame: Inclusion, 12 months ]in millimeters
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944928
|Contact: Thomas FLAMENT, MDemail@example.com|
|Contact: Sylvie LEGUEfirstname.lastname@example.org|
|CHR Orleans||Not yet recruiting|
|Orléans, France, 45067|
|Contact: Hugues MOREL, MD 02 38 51 44 44 email@example.com|
|Pulmonology Department, University Hospital, Tours||Recruiting|
|Tours, France, 37044|
|Contact: Thomas FLAMENT, MD|
|Principal Investigator: Thomas FLAMENT, MD|