Monocentric, Observational, Retrospective Study on Respiratory Physiotherapy in Severe COVID-19 Patients: the FTR-COVID Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Type of physiotherapy treatments
研究概览
简要总结
COVID-19 is an infectious disease caused by SARS-CoV2 virus. COVID-19 patients can develop a severe disease that can lead to hypoxic respiratory failure and acute respiratory distress syndrome (ARDS). Severe patients can require access to intensive care unit (ICU). Early rehabilitation is known to be effective in critically ill patients and in ARDS.
The role of respiratory physiotherapy in critical COVID-19 patients is still unclear.
The aim of this study is to describe the bundle and the timing of respiratory physiotherapy used with severe COVID-19 patients from ICU to hospital discharge. Functional condition of patients at discharge will be assessed and described.
详细描述
COVID-19 is an infectious disease caused by SARS-CoV2 virus, that first appeared in China in 2019 and in Italy in February 2020.
Approximately 80% of people infected with COVID-19 have mild to moderate disease with few symptoms, while more than 10% develop a severe disease that can lead to hypoxic respiratory failure and acute respiratory distress syndrome (ARDS). Severe patients can require access to intensive care unit (ICU) needing invasive mechanical ventilation (IMV) and hospitalization for a long period.
Early rehabilitation is known to be effective in critically ill patients and in ARDS, to reduce functional impairment due to the prolonged stay in ICU. Many works demonstrated that early rehabilitation programs in ICU correlated with faster recovery and discharge at home of ARDS patients and better outcomes in the walking test at discharge from the hospital.
Due to the recent development of COVID-19, few data and guidelines to menage severe COVID-19 patients are available and the role of respiratory physiotherapy is still unclear.
The aim of this study is to describe the bundle and the timing of respiratory physiotherapy used with severe COVID-19 patients from ICU to hospital discharge. Functional condition of patients at discharge will be assessed and described.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Having laboratory confirmed COVID-19 pneumonia
- •Developed hypoxemic acute respiratory failure (hARF) requiring access to ICU
- •Treated by respiratory physiotherapists during the hospitalization period
排除标准
- •Previously documented neurological or neuromuscular diseases
- •Passed over 1 month in bed before COVID-19 diagnosis
- •Documented cognitive impairment (mini mental state examination <24)
结局指标
主要结局
Type of physiotherapy treatments
时间窗: Through study completion, an average of 60 days
Number of each activity performed on patients among early mobilization, positioning, Uso of non invasive ventilation (NIV) and/or continuous positive airway pressure (CPAP), oxygen titration, airway clearance.
Number of physiotherapy treatments
时间窗: Through study completion, an average of 60 days
Total number of physiotherapy treatments performed on patients during hospitalization
Time of the first physiotherapy treatment
时间窗: From patient intubation to first time patient was treated by a physiotherapist; up to 60 days
Median number of days from patients intubation to the first physiotherapy treatment
次要结局
- First time standing(From patient intubation to first time standing; up to 60 days)
- First time walking(From patient intubation to first time walking; up to 60 days)
- First time sitting out of bed(From patient intubation to first time sitting out of bed; up to 60 days)
- 6 minutes walking test (6MWT)(Assessed when patients are discharged from the hospital; up to 60 days)
- 1 minute sit-to-stand test (1m-STST)(Assessed when patients are discharged from the hospital; up to 60 days)
- Lower extremity muscles strength(Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days.)
- Patients discharged to in-patient rehabilitation(Up to 60 days.)
- Exitus(From ICU admission until date of death from any cause, assessed up to 60 days.)
- Upper extremity muscles strength(Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days.)
- ICU stay length(From ICU admission to ICU discharge; up to 60 days.)
- Functional independence in ADL(Assessed when the patient is discharged from the hospital; up to 60 days.)
- Length of hospitalization(From hospital admission to hospital discharge; up to 60 days.)
- Duration of invasive mechanical ventilation (IMV)(From first day patient are mechanically ventilated to IMV stop; up to 60 days.)
- Patients returned home(Up to 60 days.)
- Patients transferred to other hospitals(Up to 60 days.)