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

Completed

• Conditions: COVID-19

• Registration Number: NCT04400461
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-22
• Primary Completion: 2021-02-25
• Study Completion: 2021-03-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medical Research Council sum score (MRC- SS).	< 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)	< 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 Outcome Measures

Name	Time	Method
Number of days on Neuromuscular Blockers	Throughout the study completion, up to 6 months	Number of days on NMB during mechanical ventilation
Baseline mobility	First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.	Baseline mobility
APACHE II score	<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.
Polyneuropathy diagnosis	Throughout the study completion, up to 6 months	Clinical or EMG polyneuropathy diagnosis confirmation
Sex	Throughout study completion , up to 6 month	Male vs Female
Body Mass Index	Throughout study completion, up to 6 months	kg/m2
Length of stay in ICU	Throughout the study completion, up to 6 months	Number of days of stay in ICU
Number of days on mechanical ventilation	Throughout the study completion, up to 6 months	Number of days on mechanical ventilation
Age	Through study completion, up to 6 months	Age in years
Episodes of prone positioning	Throughout the study completion, up to 6 months	Number of prone positioning episodes during ICU stay
Continuation of care	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.
Length of stay in hospital	Throughout the study completion, up to 6 months	Total number of days admitted to hospital

Trial Locations

Locations (2)

Medical ICU. Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Surgical ICU. Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain