Muscular Respiratory Involvement and Systemic Sclerosis (SIROCO)

Poitiers University Hospital

Status: Completed

Conditions: Diaphragmatic Electromyography; Respiratory Insufficiency; Systemic Sclerosis; Muscular Weakness; Pulmonary Function Test; Diaphragm Defect

Treatments: Diagnostic Test: Pulmonary function test

Study type: Interventional

Funder types: Other

Identifiers

NCT04118725

2019-A01047-50

Details and patient eligibility

About

Dyspnea in systemic sclerosis (ScS) constitute a major factor of functional disability.

Intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting unknown additional factors.

Diffuse fibrosing myopathy of bad prognosis have been reported in ScS.To now, muscular respiratory involvement has not been evaluated in ScS. Therefore, ScS patients (with or without dyspnea) could have underlying respiratory muscular involvement not detected by current standard of care with pulmonary function tests (PFT).

This project is the first, to the best of our knowledge, to assess frequency of respiratory muscular involvement in ScS and to evaluate a screening strategy of this involvement.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years-old
• ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital
• Written informatory consent

Exclusion criteria

• Individuals under tutorship or guardianship
• Individuals with reinforced protection: minors, judiciary or administrative decision
• No affiliation to social insurance
• Pregnancy or breastfeeding
• Associated neuromuscular disease (myasthenia, degenerative diseases)
• Bedridden individuals or with health condition not allowing realization or interpretation of PFT and/or EMG (acute cardiac and/or respiratory failure, pneumopathy)
• Individuals with pacemaker and implanted pumps, especially sensing dispositives, as defibrillators ( relative contre-indication to EMG with magnetic stimulation)
• Individuals with contre-indication to gastroesophageal probe: INR >4, oesophageal varices, suspected cardio-facial fracture, oesophageal and/or facial obstacle

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Muscular explorations

Experimental group

Description:

Pulmonary function test and diaphragmatic electromyography

Treatment:

Diagnostic Test: Pulmonary function test