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

Overview

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 Title of Study: “Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: A Cross-sectional Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: September 30, 2020

Detailed 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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Investigator Details

  • Lead Sponsor
    • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maria Natividad Seisdedos Nunez, Physiotherapist, MSc – Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
  • Overall Contact(s)
    • MarĂ­a-Natividad Seisdedos-Nunez, PT, MSc, 0034913368000, marianatividad.seisdedos@salud.madrid.org

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