Assessment of Muscular Respiratory Involvement in Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Frequency of diaphragmatic involvement among ScS patients with dyspnea and/or with suspected respiratory muscular involvement on pulmonary function tests (PFT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Frequency of diaphragmatic involvement among ScS patients with dyspnea and/or with suspected respiratory muscular involvement on pulmonary function tests (PFT)
时间窗: 4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi)
Number of patients with dyspnea (SADOUL ≥2) and/or with respiratory muscular involvement suspected on PFT (maximum inspiratory pressure (max IP) below definite z-score and/or lying/sitting low vital capacity (LVC) ratio \< 75%) having diaphragmatic muscular involvement confirmed by diaphragmatic electromyography (EMG) (latency \>8.5ms and amplitudes \<0.5mV) by neck electric phrenic stimulation and/or Pdi \<20cmH2O after magnetic stimulation
次要结局
- Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and dyspnea(4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi))
- Sensitivity, specificity, positive and negative predictive value of pulmonary function tests compared to diaphragmatic involvement confirmed by EMG and Pdi among ScS patients with suspected pulmonary muscular involvement on PFT(4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi))
- Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and general and ScS-related factors(4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi))
- Sensitivity, specificity, positive and negative predictive value of dyspnea compared to diaphragmatic involvement confirmed by EMG and Pdi(4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi))
- Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and suspected muscular respiratory on pulmonary function test(4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi))
- Correlation between diaphragmatic involvement confirmed by EMG and and/or Pdi and quality of life and functional disability(4 months maximum (maximum time between PFT realization and date to obtain EMG/Pdi))