Respiratory Physiotherapy in Severe COVID-19 Patients

Study Overview
=================
Brief 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. 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.

Detailed Description
-----------------
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.

Official Title
-----------------
Monocentric, Observational, Retrospective Study on Respiratory Physiotherapy in Severe COVID-19 Patients: the FTR-COVID Study.

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: Respiratory physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having laboratory confirmed COVID-19 pneumonia Developed hypoxemic acute respiratory failure (hARF) requiring access to ICU Treated by respiratory physiotherapists during the hospitalization period Exclusion Criteria: Previously documented neurological or neuromuscular diseases Passed over 1 month in bed before COVID-19 diagnosis Documented cognitive impairment (mini mental state examination <24)

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Respiratory physiotherapy|Respiratory physiotherapy consists of: early mobilization (passive and active mobilization, muscle-strengthening exercises, mobilization out of bed, standing, walking, ADL) patients positioning non-invasive mechanical ventilation / CPAP tracheostomy management invasive mechanical ventilation weaning airway clearance oxygen titration|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of physiotherapy treatments | Total number of physiotherapy treatments performed on patients during hospitalization | Through study completion, an average of 60 days | 
| Type of physiotherapy treatments | 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. | Through study completion, an average of 60 days | 
| Time of the first physiotherapy treatment | Median number of days from patients intubation to the first physiotherapy treatment | From patient intubation to first time patient was treated by a physiotherapist; up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First time standing | Median number of days from patients intubation to standing | From patient intubation to first time standing; up to 60 days | 
| First time walking | Median number of days from patients intubation to walking | From patient intubation to first time walking; up to 60 days | 
| First time sitting out of bed | Median number of days from patients intubation to sitting out of bed | From patient intubation to first time sitting out of bed; up to 60 days | 
| 6 minutes walking test (6MWT) | Median distance (metres) obtained at the 6MWT | Assessed when patients are discharged from the hospital; up to 60 days | 
| 1 minute sit-to-stand test (1m-STST) | Median number of sit-to-stand repetitions obtained | Assessed when patients are discharged from the hospital; up to 60 days | 
| Upper extremity muscles strength | Median upper extremity muscle strength measured by the Medical Research Council sum score (MRC-SS). The muscle scale grades muscle power on a scale of 0 (no visible muscle contraction) to 5 (active movement against full resistance). The movement tested are wrist flexion, forearm flexion and shoulder abduction. | Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days. | 
| Lower extremity muscles strength | Median lower extremity muscle strength measured by the Medical Research Council sum score (MRC-SS). The muscle scale grades muscle power on a scale of 0 (no visible muscle contraction) to 5 (active movement against full resistance). The movement tested are ankle dorsiflexion, knee extension and hip flexion. | Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days. | 
| Functional independence in ADL | Median score obtained th the Barthel Index for Activities of Daily Living (ADL). The Barthel Index measures functional independence in ADL. Scores range from 0 to 100, with higher scores indicating greater independence in ADL. | Assessed when the patient is discharged from the hospital; up to 60 days. | 
| ICU stay length | Mean number of days patients stayed in ICU | From ICU admission to ICU discharge; up to 60 days. | 
| Length of hospitalization | Mean number of days patients stayed at the hospital | From hospital admission to hospital discharge; up to 60 days. | 
| Duration of invasive mechanical ventilation (IMV) | Mean number of days patients were invasively mechanically ventilated | From first day patient are mechanically ventilated to IMV stop; up to 60 days. | 
| Patients returned home | Number of patients that following hospital discharge returned home | Up to 60 days. | 
| Patients discharged to in-patient rehabilitation | Number of patients that were discharged from acute hospital to in-patient rehabilitation | Up to 60 days. | 
| Patients transferred to other hospitals | Number of patients that following hospital discharge were transferred to other hospitals | Up to 60 days. | 
| Exitus | Number of patients that died from any cause during hospitalization | From ICU admission until date of death from any cause, assessed up to 60 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, Respiratory Physiotherapy, Early Rehabilitation