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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400461
• Other study ID #: 165/20
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 1, 2021
• Est. primary completion date: February 25, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
Spain	Medical ICU. Hospital Universitario Ramón y Cajal	Madrid
Spain	Surgical ICU. Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

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