Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: an Observational Cohort Study

Conditions
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COVID-19

Intervention / Treatment
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* Other: Data collection and clinical testing of subjects


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects diagnosed with COVID-19 who have required admission to ICU for invasive mechanical ventilation; have received invasive ventilation > 24 hours; have been successfully weaned from mechanical ventilation > 48 hours; were independently able to mobilise prior to current hospital admission (this includes subjects who used a walking stick or another gait aid to mobilise. Exclusion Criteria: subjects or proxies with inability to communicate in Spanish fluently; cognitive impairment prior to ICU admission; proven neurological impairment or neuromuscular disorder; Cerebrovascular Accident during hospital stay; previous organ transplant; pregnancy; unstable fractures or any other injuries that would require medical bed rest.

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

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data collection and clinical testing of subjects|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical function, functional outcomes, strength, intensive care unit, rehabilitation