Clinical trial NCT04400461: Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation
Official title: Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: physical function
functional outcomes
strength
intensive care unit
rehabilitation
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with COVID-19 who require admission to the ICU for invasive mechanical ventilation.

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.

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.

Primary outcomes:
measure: Medical Research Council sum score (MRC- SS).
timeFrame: < 48 hours before ICU discharge
measure: Medical Research Council sum score (MRC- SS).
timeFrame: < 24 hours before hospital discharge
measure: The Functional Status Score for the ICU (FSS-ICU)
timeFrame: < 24 hours before hospital discharge
Secondary outcomes:
measure: Age
timeFrame: Through study completion, up to 6 months
measure: Sex
timeFrame: Throughout study completion , up to 6 month
measure: Body Mass Index
timeFrame: Throughout study completion, up to 6 months
measure: Baseline mobility
timeFrame: First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
measure: APACHE II score
timeFrame: <24 hours after ICU admission
measure: Length of stay in ICU
timeFrame: Throughout the study completion, up to 6 months
measure: Number of days on mechanical ventilation
timeFrame: Throughout the study completion, up to 6 months
measure: Polyneuropathy diagnosis
timeFrame: Throughout the study completion, up to 6 months
measure: Number of days on Neuromuscular Blockers
timeFrame: Throughout the study completion, up to 6 months
measure: Episodes of prone positioning
timeFrame: Throughout the study completion, up to 6 months
measure: Length of stay in hospital
timeFrame: Throughout the study completion, up to 6 months
measure: Continuation of care
timeFrame: Throughout the study completion, up to 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Medical ICU. Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Surgical ICU. Hospital Universitario Ramón y Cajal
Study officials:
References: