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

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.

Completed
COVID-19

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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Spain
Locations

Medical ICU. Hospital Universitario Ramón y Cajal
Madrid, Spain

Surgical ICU. Hospital Universitario Ramón y Cajal
Madrid, Spain

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
NCT Number
Keywords
physical function
functional outcomes
strength
Intensive care unit
Rehabilitation
MeSH Terms
COVID-19