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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Data collection and clinical testing of subjects

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 Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Medical ICU. Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28034
    • Surgical ICU. Hospital Universitario Ramón y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects diagnosed with COVID-19 who require admission to the ICU for invasive mechanical ventilation.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Research Council sum score (MRC- SS).	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.	< 48 hours before ICU discharge
Medical Research Council sum score (MRC- SS).	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.	< 24 hours before hospital discharge
The Functional Status Score for the ICU (FSS-ICU)	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.	< 24 hours before hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age in years	Through study completion, up to 6 months
Sex	Male vs Female	Throughout study completion , up to 6 month
Body Mass Index	kg/m2	Throughout study completion, up to 6 months
Baseline mobility	Baseline mobility	First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
APACHE II score	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.	<24 hours after ICU admission
Length of stay in ICU	Number of days of stay in ICU	Throughout the study completion, up to 6 months
Number of days on mechanical ventilation	Number of days on mechanical ventilation	Throughout the study completion, up to 6 months
Polyneuropathy diagnosis	Clinical or EMG polyneuropathy diagnosis confirmation	Throughout the study completion, up to 6 months
Number of days on Neuromuscular Blockers	Number of days on NMB during mechanical ventilation	Throughout the study completion, up to 6 months
Episodes of prone positioning	Number of prone positioning episodes during ICU stay	Throughout the study completion, up to 6 months
Length of stay in hospital	Total number of days admitted to hospital	Throughout the study completion, up to 6 months
Continuation of care	Home with no follow-up physiotherapy, home with domiciliary or out-patient physiotherapy, rehabilitation facility, care home, transfer to another acute hospital.	Throughout the study completion, up to 6 months

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): February 25, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: intensive care unit; rehabilitation; physical function; strength; functional outcomes
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 165/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No