Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Medical Research Council sum score (MRC- SS). [< 48 hours before ICU discharge]
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.
- Medical Research Council sum score (MRC- SS). [< 24 hours before hospital discharge]
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.
- The Functional Status Score for the ICU (FSS-ICU) [< 24 hours before hospital discharge]
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.
Secondary Outcome Measures
- Age [Through study completion, up to 6 months]
Age in years
- Sex [Throughout study completion , up to 6 month]
Male vs Female
- Body Mass Index [Throughout study completion, up to 6 months]
kg/m2
- Baseline mobility [First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.]
Baseline mobility
- APACHE II score [<24 hours after ICU admission]
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.
- Length of stay in ICU [Throughout the study completion, up to 6 months]
Number of days of stay in ICU
- Number of days on mechanical ventilation [Throughout the study completion, up to 6 months]
Number of days on mechanical ventilation
- Polyneuropathy diagnosis [Throughout the study completion, up to 6 months]
Clinical or EMG polyneuropathy diagnosis confirmation
- Number of days on Neuromuscular Blockers [Throughout the study completion, up to 6 months]
Number of days on NMB during mechanical ventilation
- Episodes of prone positioning [Throughout the study completion, up to 6 months]
Number of prone positioning episodes during ICU stay
- Length of stay in hospital [Throughout the study completion, up to 6 months]
Total number of days admitted to hospital
- Continuation of care [Throughout the study completion, up to 6 months]
Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital.
Eligibility Criteria
Criteria
Inclusion Criteria:
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subjects diagnosed with COVID-19 who have required admission to ICU for invasive mechanical ventilation;
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have received invasive ventilation > 24 hours;
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have been successfully weaned from mechanical ventilation > 48 hours;
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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:
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subjects or proxies with inability to communicate in Spanish fluently;
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cognitive impairment prior to ICU admission;
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proven neurological impairment or neuromuscular disorder;
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Cerebrovascular Accident during hospital stay;
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previous organ transplant;
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pregnancy;
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unstable fractures or any other injuries that would require medical bed rest.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical ICU. Hospital Universitario Ramón y Cajal | Madrid | Spain | 28034 | |
| 2 | Surgical ICU. Hospital Universitario Ramón y Cajal | Madrid | Spain | 28034 |
Sponsors and Collaborators
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 165/20