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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: COVID-19

Treatments: Other: Data collection and clinical testing of subjects

Study type: Observational

Funder types: Other

Identifiers

NCT04400461

165/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.