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

NCT ID: NCT04400461

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2021-03-01

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Maria Natividad Seisdedos Nunez

Physiotherapist, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical ICU. Hospital Universitario Ramón y Cajal

Madrid, , Spain

Surgical ICU. Hospital Universitario Ramón y Cajal

Madrid, , Spain

Countries

Spain

Other Identifiers

165/20

Identifier Type: -

Identifier Source: org_study_id