ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution

NCT03944928 | Completed

• 1 other identifier: RIPH3-RNI19-TOUPIE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Lung ultrasound; B lines; Pleural irregularity

Outcome Measures

Primary Outcomes (3)

• Change of the B-line score from inclusion to 12 months

  number of line

  Inclusion, 12 months

• Change of pleural line irregularity from inclusion to 12 months

  Percentage

  Inclusion, 12 months

• Change of pleural line thickness from inclusion to 12 months

  in millimeters

  Inclusion, 12 months

Interventions

Lung ultrasound OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with idiopathic pulmonary fibrosis

You may qualify if:

• more than 18 years-old
• diagnosis of IPF validated in a multidisciplinary consultation meeting (RCP) according to French recommendations

You may not qualify if:

• pregnant or lactating women
• evolutive pulmonary infectious disease
• other forms of diffuse interstitial lung disease
• opposition to the data collection

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (2)

CHR Orleans

Orléans, 45067, France

Location

Pulmonology Department, University Hospital, Tours

Tours, 37044, France

Location

Related Publications (1)

• Legue S, Marchand-Adam S, Plantier L, Bayeh BA, Morel H, Mangiapan G, Flament T. ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution (TOUPIE): research protocol of a multicentric prospective study. BMJ Open. 2021 Mar 25;11(3):e039078. doi: 10.1136/bmjopen-2020-039078.

  PMID: 33766834 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 10, 2019
• Study Start: June 11, 2019
• Primary Completion: August 3, 2020
• Study Completion: September 9, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

FR (2)