Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients: a Multicentric, National, Observational, Retrospective Study.

Conditions
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COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Procedure: Early physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Previuos cognitive deficit (Mini menatal state examination <20)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>COVID-19 ICU-admitted patients that did not received physiotherapy interventions during ICU stay. | |
| Physiotherapy<br>COVID-19 ICU-admitted patients that received physiotherapy interventions during ICU stay. | Procedure: Early physiotherapy<br>* 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.<br>* Other names: early rehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free days (VFD) and alive at day 28 | 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. | Up to 28 days after neuromuscular blokade stop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay duration | Mean days of ICU stay | From ICU admission to ICU discharge; up to 60 days. | 
| PaO2/FiO2 | Mean measure of PaO2/FiO2 | At ICU discharge; up to 60 days | 
| ICU survival rate | Number of patients that survived ICU stay | From ICU admission until date of death from any cause, during ICU stay; up to 100 days. | 
| hospital survival rate | Number of patients that survived hospitalization | From ICU admission until date of death from any cause, during hospitalization | 
| 90 days survival rate | Number of patients that survived during 90 days after neuromuscular blokade stop | From ICU admission until date of death from any cause, assessed up to 90 days after neuromuscular blokade removal |