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Completed

NCT Number: NCT04400461

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical ICU. Hospital Universitario Ramón y Cajal, Madrid, Spain

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data collection and clinical testing of subjects

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. Age

    Time frame: Through study completion, up to 6 months

    Age in years

  2. Sex

    Time frame: Throughout study completion , up to 6 month

    Male vs Female

  3. Body Mass Index

    Time frame: Throughout study completion, up to 6 months

    kg/m2

  4. Baseline mobility

    Time frame: First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.

    Baseline mobility

  5. 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.

  6. Length of stay in ICU

    Time frame: Throughout the study completion, up to 6 months

    Number of days of stay in ICU

  7. Number of days on mechanical ventilation

    Time frame: Throughout the study completion, up to 6 months

    Number of days on mechanical ventilation

  8. Polyneuropathy diagnosis

    Time frame: Throughout the study completion, up to 6 months

    Clinical or EMG polyneuropathy diagnosis confirmation

  9. Number of days on Neuromuscular Blockers

    Time frame: Throughout the study completion, up to 6 months

    Number of days on NMB during mechanical ventilation

  10. Episodes of prone positioning

    Time frame: Throughout the study completion, up to 6 months

    Number of prone positioning episodes during ICU stay

  11. Length of stay in hospital

    Time frame: Throughout the study completion, up to 6 months

    Total number of days admitted to hospital

  12. 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.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 22, 2020
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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