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

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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Updated on 5 August 2020
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mechanical ventilation
covid-19

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.

Description

DESIGN: A cross-sectional 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.

Details
Condition Covid 19
Age 18years - 80years
Treatment Data collection and clinical testing of subjects
Clinical Study IdentifierNCT04400461
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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