Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients: a Multicentric, National, Observational, Retrospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 4
- 主要终点
- Ventilator-free days (VFD) and alive at day 28
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.
Early rehabilitation is known to be effective in critically ill subjects. The role of physiotherapy in severe COVID-19 patients is still unclear and few guidelines have been proposed so far. Aim of this study is to assess efficacy of early rehabilitation for severe ICU-admitted COVID-19 patients as compared to a group that did not received physiotherapy treatment in ICU.
详细描述
COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which emerged in China in December 2019 and in Italy in February 2020. A large proportion of infected people have mild clinical manifestations, whereas >10% develop a severe disease, which could evolve into acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) requiring intensive care unit (ICU) admission. A high proportion of ICU patients need invasive mechanical ventilation (IMV) and about 50% of the ICU-admitted patients die. The median age of ICU COVID-19 patients was <65 years and the mortality in patients aged <63 years ranges from 15 to 20%.
Early rehabilitation is safe and effective in critically ill patients and, in patients with ARDS, it helps to reduce the functional impairment due to the prolonged stay in ICU. Preliminary data suggest the implementation of early and active mobilization programs, as well as airway clearance, for patients with severe forms of COVID-19. To date, the role of respiratory physiotherapy in severe COVID-19 patients is still unclear.
Aim of this study is to assess efficacy of early rehabilitation for severe ICU-admitted COVID-19 patients as compared to a group that did not recevied physiotherapy treatment in ICU. Physiotherapy efficacy is evaluated in terms of ventilator free days (VFD) during the first 30 days after neuromuscular blockade stop.
Moreover, duration of ICU stay and patient functional status at ICU discharge will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 physiotherapists during the ICU stay
- •Stopped the neuromuscular blokade treatment
排除标准
- •Previuos cognitive deficit (Mini menatal state examination <20)
结局指标
主要结局
Ventilator-free days (VFD) and alive at day 28
时间窗: Up to 28 days after neuromuscular blokade stop
To determine if early physiotherapy, as compared to no physiotherapy treatment, increases the number of ventilator-free days (VFD) and alive at day 28 in severe COVID-19 ICU-admitted patients.
次要结局
- ICU stay duration(From ICU admission to ICU discharge; up to 60 days.)
- PaO2/FiO2(At ICU discharge; up to 60 days)
- ICU survival rate(From ICU admission until date of death from any cause, during ICU stay; up to 100 days.)
- hospital survival rate(From ICU admission until date of death from any cause, during hospitalization)
- 90 days survival rate(From ICU admission until date of death from any cause, assessed up to 90 days after neuromuscular blokade removal)