An observational study in COVID-19, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-16.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 84 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.
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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 1st, that were treated by respiratory physiotherapists during the whole hospitalization period.
Exclusion Criteria:
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
Number of physiotherapy treatments
Total number of physiotherapy treatments performed on patients during hospitalization
Time frame: 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.
Time frame: 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
Time frame: From patient intubation to first time patient was treated by a physiotherapist; up to 60 days
First time standing
Median number of days from patients intubation to standing
Time frame: From patient intubation to first time standing; up to 60 days
First time walking
Median number of days from patients intubation to walking
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed when the patient is discharged from the hospital; up to 60 days.
ICU stay length
Mean number of days patients stayed in ICU
Time frame: From ICU admission to ICU discharge; up to 60 days.
Length of hospitalization
Mean number of days patients stayed at the hospital
Time frame: 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
Time frame: 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
Time frame: Up to 60 days.
Patients discharged to in-patient rehabilitation
Number of patients that were discharged from acute hospital to in-patient rehabilitation
Time frame: Up to 60 days.
Patients transferred to other hospitals
Number of patients that following hospital discharge were transferred to other hospitals
Time frame: Up to 60 days.
Exitus
Number of patients that died from any cause during hospitalization
Time frame: From ICU admission until date of death from any cause, assessed up to 60 days.
Plan to share: No
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico