Respiratory Physiotherapy in Severe COVID-19 Patients
- Conditions
- COVID-19
- Registration Number
- NCT04459819
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Having laboratory confirmed COVID-19 pneumonia
- Developed hypoxemic acute respiratory failure (hARF) requiring access to ICU
- Treated by respiratory physiotherapists during the hospitalization period
- Previously documented neurological or neuromuscular diseases
- Passed over 1 month in bed before COVID-19 diagnosis
- Documented cognitive impairment (mini mental state examination <24)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Type of physiotherapy treatments Through study completion, an average of 60 days 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.
Number of physiotherapy treatments Through study completion, an average of 60 days Total number of physiotherapy treatments performed on patients during hospitalization
Time of the first physiotherapy treatment From patient intubation to first time patient was treated by a physiotherapist; up to 60 days Median number of days from patients intubation to the first physiotherapy treatment
- Secondary Outcome Measures
Name Time Method First time walking From patient intubation to first time walking; up to 60 days Median number of days from patients intubation to walking
First time standing From patient intubation to first time standing; up to 60 days Median number of days from patients intubation to standing
First time sitting out of bed From patient intubation to first time sitting out of bed; up to 60 days Median number of days from patients intubation to sitting out of bed
6 minutes walking test (6MWT) Assessed when patients are discharged from the hospital; up to 60 days Median distance (metres) obtained at the 6MWT
1 minute sit-to-stand test (1m-STST) Assessed when patients are discharged from the hospital; up to 60 days Median number of sit-to-stand repetitions obtained
Lower extremity muscles strength Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days. 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.
Patients discharged to in-patient rehabilitation Up to 60 days. Number of patients that were discharged from acute hospital to in-patient rehabilitation
Exitus From ICU admission until date of death from any cause, assessed up to 60 days. Number of patients that died from any cause during hospitalization
Upper extremity muscles strength Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days. 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.
ICU stay length From ICU admission to ICU discharge; up to 60 days. Mean number of days patients stayed in ICU
Functional independence in ADL Assessed when the patient is discharged from the hospital; up to 60 days. 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.
Length of hospitalization From hospital admission to hospital discharge; up to 60 days. Mean number of days patients stayed at the hospital
Duration of invasive mechanical ventilation (IMV) From first day patient are mechanically ventilated to IMV stop; up to 60 days. Mean number of days patients were invasively mechanically ventilated
Patients returned home Up to 60 days. Number of patients that following hospital discharge returned home
Patients transferred to other hospitals Up to 60 days. Number of patients that following hospital discharge were transferred to other hospitals
Trial Locations
- Locations (1)
Department of Pathophysiology and Transplantation, University of Milan Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
馃嚠馃嚬Milan, Italy