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Little is known about the physical function outcomes in patients with severe COVID-19 patients who are admitted to Intensive Care Unit (ICU) for invasive mechanical ventilation. The purpose of this study is to evaluate the short-term impact on physical function before hospital discharge in subjects with severe COVID-19 who have survived ICU admission for invasive mechanical ventilation.
DESIGN: An observation cohort study conducted in a tertiary hospital.
METHODS: Data will be collected from patients along the ICU-hospital discharge continuum, will be analysed and non-parametric tests will be used to explore association between variables.
Outcome measures: Muscle strength, as a component of physical function, will be evaluated with the Medical Research Council sum score (MRC- SS) at discharge from ICU and at hospital discharge; the Functional Status Score for the ICU (FSS-ICU) will also be assessed at hospital discharge. Data on participants' demographics, ICU admission and hospital admission will also be collected.
SIGNIFICANCE OF THE RESEARCH: Understanding how physical function is affected in patients with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes in this specific group of patients. Findings from this study may be useful to design future larger cohort studies and experimental trials.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection and clinical testing of subjects | Other | Clinical Testing: muscle strength. Muscle strength, as a component of physical function, will be assessed with the Medical Research Council sum score (MRC- SS) at discharge from the ICU and at discharge from the hospital. Clinical testing: physical function. The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks at discharge from hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Research Council sum score (MRC- SS). | Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body. | < 48 hours before ICU discharge |
| Medical Research Council sum score (MRC- SS). | Physical examination will be performed to carry out manual muscle testing of strength in 6 different muscle groups of the upper limb and lower limb on both sides of the body. | < 24 hours before hospital discharge |
| The Functional Status Score for the ICU (FSS-ICU) | The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks. Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform) to 7 (complete independence).The total FSS-ICU score ranges from 0 to 35, with higher scores indicating better physical functioning. | < 24 hours before hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age in years | Through study completion, up to 6 months |
| Sex | Male vs Female | Throughout study completion , up to 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects diagnosed with COVID-19 who require admission to the ICU for invasive mechanical ventilation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical ICU. Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain | |||
| Surgical ICU. Hospital Universitario Ramón y Cajal |
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| Body Mass Index | kg/m2 | Throughout study completion, up to 6 months |
| Baseline mobility | Baseline mobility | First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test. |
| APACHE II score | Acute Physiology and Chronic Health Evaluation II score.The APACHE II score ranges from 0 to 71 points. Higher scores correspond to more severe disease and a higher risk of death. | <24 hours after ICU admission |
| Length of stay in ICU | Number of days of stay in ICU | Throughout the study completion, up to 6 months |
| Number of days on mechanical ventilation | Number of days on mechanical ventilation | Throughout the study completion, up to 6 months |
| Polyneuropathy diagnosis | Clinical or EMG polyneuropathy diagnosis confirmation | Throughout the study completion, up to 6 months |
| Number of days on Neuromuscular Blockers | Number of days on NMB during mechanical ventilation | Throughout the study completion, up to 6 months |
| Episodes of prone positioning | Number of prone positioning episodes during ICU stay | Throughout the study completion, up to 6 months |
| Length of stay in hospital | Total number of days admitted to hospital | Throughout the study completion, up to 6 months |
| Continuation of care | Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital. | Throughout the study completion, up to 6 months |
| Madrid |
| 28034 |
| Spain |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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