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

NCT04400461 | Completed

• 1 other identifier: 165/20
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

physical function; functional outcomes; strength; intensive care unit; rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Age

  Through study completion, up to 6 months

• Sex

  Throughout study completion , up to 6 month

• Body Mass Index

  Throughout study completion, up to 6 months

• Baseline mobility

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

• APACHE II score

  <24 hours after ICU admission

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Medical ICU. Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Surgical ICU. Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 22, 2020
• Study Start: May 15, 2020
• Primary Completion: February 25, 2021
• Study Completion: March 1, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)