Muscular Respiratory Involvement and Systemic Sclerosis
NCT ID: NCT04118725
Last Updated: 2021-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2019-10-21
2021-07-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Muscular explorations
Pulmonary function test and diaphragmatic electromyography
Pulmonary function test
Diaphragmatic electromyography with measurement of transdiaphragmatic pressure in cases of dyspnea and/or abnormal pulmonary function test (maximum inspiratory pressure and/or lying/seating low vital capacity ratio)
Interventions
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Pulmonary function test
Diaphragmatic electromyography with measurement of transdiaphragmatic pressure in cases of dyspnea and/or abnormal pulmonary function test (maximum inspiratory pressure and/or lying/seating low vital capacity ratio)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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Chu de Poitiers
Poitiers, , France
Countries
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Other Identifiers
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2019-A01047-50
Identifier Type: -
Identifier Source: org_study_id
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