Long-term Follow-up Findings of Inpatients for COVID-19 Pneumonia Related to Lung Functions, Radiology and Exercise Capacity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Lung diffusion capacity for carbon monoxide (DLCO)
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus (SARS-CoV-2) that can progress to severe multiorgan disease requiring hospitalization. The medium and long-term impact in survivors of COVID-19 on lung function, imaging by thoracic CT, exercise capacity, and health-related quality of life and the relation of these parameters remains to be determined.
详细描述
Aim: To evaluate medium to late (visit 1: 6-12 months after hospital discharge) effects of COVID-19 on lung function, exercise capacity, thoracic CT findings, symptoms and HRQoL in patients with confirmed diagnosis of SARS-CoV-2 infection and the relation between these parameters.
Material and methods
Prospective cohort of subjects with laboratory and/or thoracic CT confirmed COVID-19 who were treated as inpatients. Participants will perform spirometry, lung diffusion capacity of carbon monoxide, 6-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET) after 6-12 months (Visit 1) of COVID-19. Clinical, laboratory and chest image data during the COVID-19 hospitalization will be obtained from medical records.
The minimum sample size was estimated as 37 participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with Covid 19 diagnosis
- •Ability to read and speak
- •Signed informed consent.
- •Able to perform exercise testing and walking
排除标准
- •Subjects with limited exercise capacity
结局指标
主要结局
Lung diffusion capacity for carbon monoxide (DLCO)
时间窗: at 6-12 months after discharge
DLCO (%predicted); DLCO/alveolar volume- DLCO/VA (%predicted)
6-minute walk test distance
时间窗: at 6-12 months after discharge
m
Dyspnea during exercise
时间窗: at 6-12 months after discharge
from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale
Oxygen uptake at peak exercise
时间窗: at 6-12 months after discharge
from incremental Cardiopulmonary exercise test (% of predicted)
Thoracic CT findings
时间窗: in the first week of pneumonia and at 6-12 months after discharge
lung parenchymal abnormalities as percentage of occupied lung
Minute-ventilation/carbon dioxide output during exercise
时间窗: at 6-12 months after discharge
from incremental Cardiopulmonary exercise test (L/L)
Forced vital capacity (FVC)
时间窗: at 6-12 months after discharge
in ml
Short-form 36 questionnaire (SF-36)
时间窗: at 6-12 months after discharge
scores range between 0 and 100 with higher scores indicating a better HRQoL
FEV1/FVC ratio
时间窗: at 6-12 months after discharge
in %
Forced expiratory volume in 1 second
时间窗: at 6-12 months after discharge
in ml and %predicted
Forced vital capacity %predicted (FVC%)
时间窗: at 6-12 months after discharge
in %
次要结局
- Weaning from intubation(in the period of intensive care)
- Time to hospital discharge(in hospital)
- Weaning from noninvasive mechanical ventilation(in hospital)
- Mortality(in hospital and at 6-12 months after discharge)
- ICU discharge(in hospital)
- Signs and symptoms(in the first week of pneumonia and at 6-12 months after discharge)
- Weaning from supplemental oxygen(in hospital)
研究者
Fatma Işıl Uzel
MD
Koc University Hospital