Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients.
Condition: COVID-19 Acute Respiratory Distress Syndrome
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Early physiotherapy
Intervention type(s): Procedure
Intervention description(s): Respiratory physiotherapy included:
early and functional mobilization: passive and active mobilization, muscle strengthening, improving independence in activities of daily living (ADL), sitting out of bed, standing, walking;
patient positioning to achieve better ventilation/perfusion ratio and gas exchange;
airway clearance;
aerosol administration;
invasive mechanical ventilation weaning;
use of non-invasive mechanical ventilation (NIMV) and continuous positive airway pressure (CPAP);
tracheostomy management and weaning;
swallowing assessment;
management of oxygen delivery;
lung expansion;
patient assessment and functional scale administration.
Other intervention name(s): respiratory physiotherapy; early rehabilitation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Investigators will study patients accessing acute hospital ICU with hypoxemic acute
        respiratory failure (hARF) due to laboratory confirmed COVID-19 pneumonia form March 1st to
        May 30th.