Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The change diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia.
研究概览
简要总结
The current state of knowledge shows the presence of respiratory sequelae after acute infection with COVID-19 and the importance of these long-term respiratory dysfunctions have to be determined.
Aim of our study is describe diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia at 3 and 6 months after the acute episode.
详细描述
patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France) will be included to follow the impact of severe acute respiratory syndrom coronavirus 2 on pulmonary function, diaphragm function and exercice capacity. Surviving patients will be evaluated at 3 and 6 months after hospital discharge. The assesment will include diaphragm ultrasonography, spirometry (FEV1,FVC), carbon monoxide transfert (TLCO adjusted for haemoglobin), inspiratory an expiratory respiratory muscle strength (Pimax and Pemax) and 6 minutes walk distance (6MWD).The main outcome will be diaphragm excursion assessed by ultrasound.
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
- •SARS-CoV-2 infection proven by RT-PCR.
- •Patient hospitalised for the management of SARS-CoV-2 infection and included 3 months after the end of his hospitalisation at the CHU of Limoges.
- •Patient of legal age.
- •Patient affiliated to a social security regime.
- •Patient having given informed consent
排除标准
- •Known pregnancy.
- •Patients who are contraindicated to perform the 6-minute walk test.
- •Patients unable to understand or adhere to the protocol.
- •Patients deprived of liberty.
- •Patients under court order, tutorship or curatorship.
- •Minor patients
研究组 & 干预措施
Cohort
All patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France)
干预措施: diaphragm ultrasonography (Diagnostic Test)
结局指标
主要结局
The change diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia.
时间窗: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
Diaphragmatic amplitude assessed by ultrasound at M0 and M3.
次要结局
- the correlation between the values of diaphragmatic travel and Pi max and Pe max at M0 and M3.(at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges)
- the difference in diaphragmatic amplitude between M0 and M3.(at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges)
- the difference in FEV1 between M0 and M3.(at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges)
- the difference in FVC between M0 and M3.(at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges)
- the difference in DLCO between M0 and M3.(at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges)
- the difference in Pi max and Pe max between M0 and M3.(at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges)
- dyspnoea between M0 and M3.(at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges)
- the functional capacity between M0 and M3.(at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges)