COVID-19NCT04400461
Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation
An observational study of COVID-19, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Data collection and clinical testing of subjects
- How many people
- 71 participants
- Where
- 2 sitesSpain
- Study dates
- 15 May 2020to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Subjects diagnosed with COVID-19 who require admission to the ICU for invasive mechanical ventilation.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Medical ICU. Hospital Universitario Ramón y Cajal
Madrid, 28034
Surgical ICU. Hospital Universitario Ramón y Cajal
Madrid, 28034
About this study
Official title: Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: an Observational Cohort Study
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.
Read the 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
- Being tested
- Data collection and clinical testing of subjects
- Keywords
- physical function, functional outcomes, strength, intensive care unit, rehabilitation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and clinical testing of subjectsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: < 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.
Measured: < 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.
Measured: < 24 hours before hospital discharge
Secondary outcomes (12)
Age
Age in years
Measured: Through study completion, up to 6 months
Sex
Male vs Female
Measured: Throughout study completion , up to 6 month
Body Mass Index
kg/m2
Measured: Throughout study completion, up to 6 months
Baseline mobility
Baseline mobility
Measured: First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
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.
Measured: <24 hours after ICU admission
Length of stay in ICU
Number of days of stay in ICU
Measured: Throughout the study completion, up to 6 months
Number of days on mechanical ventilation
Number of days on mechanical ventilation
Measured: Throughout the study completion, up to 6 months
Polyneuropathy diagnosis
Clinical or EMG polyneuropathy diagnosis confirmation
Measured: Throughout the study completion, up to 6 months
Number of days on Neuromuscular Blockers
Number of days on NMB during mechanical ventilation
Measured: Throughout the study completion, up to 6 months
Episodes of prone positioning
Number of prone positioning episodes during ICU stay
Measured: Throughout the study completion, up to 6 months
Length of stay in hospital
Total number of days admitted to hospital
Measured: Throughout the study completion, up to 6 months
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.
Measured: Throughout the study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start15 May 2020
- Primary completion25 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Natividad Seisdedos Nunez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400461
- Sponsor's protocol ID
- 165/20
- Status last verified
- Apr 2021
- First submitted
- 20 May 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation: an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04400461
- Acronym / sponsor ID
- 165/20
- Conditions
- COVID-19
- Keywords
- physical function, functional outcomes, strength, intensive care unit, rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with COVID-19 who require admission to the ICU for invasive mechanical ventilation.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection and clinical testing of subjectsClinical 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. | Other | – |
Primary outcome
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.
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.
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.
12 secondary outcomes
Age
Time frame: Through study completion, up to 6 months
Sex
Time frame: Throughout study completion , up to 6 month
Body Mass Index
Time frame: Throughout study completion, up to 6 months
Baseline mobility
Time frame: First day the patient can cooperate with assessment according to the ' 5 Standard Questions' test.
APACHE II score
Time frame: <24 hours after ICU admission
Length of stay in ICU
Time frame: Throughout the study completion, up to 6 months
Number of days on mechanical ventilation
Time frame: Throughout the study completion, up to 6 months
Polyneuropathy diagnosis
Time frame: Throughout the study completion, up to 6 months
Number of days on Neuromuscular Blockers
Time frame: Throughout the study completion, up to 6 months
Episodes of prone positioning
Time frame: Throughout the study completion, up to 6 months
Length of stay in hospital
Time frame: Throughout the study completion, up to 6 months
Continuation of care
Time frame: Throughout the study completion, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Research Council sum score (MRC- SS). (time frame: < 48 hours before ICU discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.