An observational study in Post Intensive Care Unit Syndrome and Covid19, sponsored by Gaziosmanpasa Research and Education Hospital. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Gaziosmanpasa Research and Education Hospital · Observational
The present assessment tools for assessing physical function after intensive care unit (ICU) can be categorized as (1) functional tests (2) walk tests (3) strength test (4) Health-related quality of life (HRQOL). Strength tests such as Medical Research Council Scale and HRQOL (e.g. Short form-36 (SF-36) tests may require awakening and appropriate mental health. However, mental impairments were seen in a considerable number of patients (2). Walk tests such as Six-Minute Walk Test (6MWT) or Timed Up\&Go (TUG) can be impractical, some patients could not be able to perform these due to severe impairment. These tests require space to perform and may require management of several drips, drains, and oxygen delivery systems while the patient is walking and turning which render the test difficult to carry out. Among these three specific tools, CPAx seems to be the assessment tool that can be considered easy to use in the clinical setting due to the short time required for assessment and relatively minimal use of equipment (hand dynamometer for grip strength measurement).
This study aims to investigate validation of Chelsea Critical Care Physical Assessment Tool in the assessment of the functional status of COVID patients discharged from ICU and investigate the feasibility of commonly used assessment tools for assessing physical function after ICU in COVID patients discharged from ICU.
The present assessment tools for assessing physical function after intensive care unit (ICU) can be categorized as (1) functional tests (2) walk tests (3) strength test (4) Health-related quality of life (HRQOL). Strength tests such as Medical Research Council Scale and HRQOL (e.g. SF-36) tests may require awakening and appropriate mental health. However, mental impairments were seen in a considerable number of patients (2). Walk tests such as Six-Minute Walk Test (6MWT) or Timed Up\&Go (TUG) can be impractical, some patients could not be able to perform these due to severe impairment. These tests require space to perform and may require management of several drips, drains, and oxygen delivery systems while the patient is walking and turning which render the test difficult to carry out. Among functional tests, the Physical Function in Intensive Care Test (PFIT) Functional Status Score for the ICU and the Chelsea Critical Care Physical Assessment Tool (CPAx) are specifically designed to assess function after ICU while Barthel and Katz are nonspecific to this population. According to a systematic review of 26 different outcome measures, the CPAx and the Physical Function in Intensive Care Test demonstrated the strongest psychometric properties, however, the Physical Function in Intensive Care Test has a significant floor effect. The PFIT and CPAx may be more suitable for the assessment of patients who may never reach the ability to perform submaximal exercise tests.
Among these three specific tools, CPAx seems to be the assessment tool that can be considered easy to use in the clinical setting due to the short time required for assessment and relatively minimal use of equipment (hand dynamometer for grip strength measurement).
Patients over 18 years of age who suffered COVID-19 pneumonia and stayed in ICU and discharged will be included in the study. Patients who are able to follow at least 2 of the commands from De Jonghe and colleagues' awakening criteria will be evaluated within 48 hours discharge. Patients will be assessed by using Chelsea Critical Care Physical Assessment Tool, Barthel Index, Katz Index, 5 times Sit-To-Stand test, 30 seconds Sit-To-Stand test, Glasgow coma scale, handheld dynamometers, Medical Research Council sum score (MRC-SS) and modified Medical Research Council dyspnea scale. The number (%) of the patients who will be able to complete the tests will be recorded. Another physiatrist will also complete Chelsea Critical Care Physical Assessment Tool at the same time without discussion and will be blinded to score of the other rater. Patients' demographic characteristics such as age, gender, comorbidities will be recorded. Length of stay in ICU, duration of mechanical ventilation, history of Extra Corporeal Membrane Oxygenation (ECMO), presence of tracheostomy, intubation status, the sequential organ failure assessment score (SOFA score) at the day of ICU admission and acute physiology and chronic health evaluation (APACHE II) on ICU admission will be recorded.
For construct validation, the correlation between CPAx and Barthel, Katz, Medical Research Council sum score and grip strength will be calculated. Kappa and weighed Kappa analysis will be conducted for inter-rater reliability. Descriptive analysis (Number (%) of the patients who will be able to complete the tests) will be performed to assess feasibility.
This study aims to investigate validation of the Chelsea Critical Care Physical Assessment Tool in the assessment of the functional status of COVID patients discharged from ICU and investigate the feasibility of commonly used assessment tools for assessing physical function after ICU in COVID patients discharged from ICU.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 16 is below the median of 260 across 3,188 observational studies indexed under COVID-19.
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Adult patients (patients over 18 years of age) who suffered COVID-19 pneumonia and stayed in ICU and discharged and who who are able to follow at least 2 of the commands from De Jonghe and colleagues' awakening criteria (presented below)
De Jonghe and colleagues' awakening criteria
Can patient follow the command? "Open/close your eyes." "Look at me." "Open your mouth and stick out your tongue." "Nod your head." "Raise your eyebrows when I have counted to 5."
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Can patient follow the command? "Open/close your eyes." "Look at me." "Open your mouth and stick out your tongue." "Nod your head." "Raise your eyebrows when I have counted to 5."
Exclusion Criteria:
Patients who suffered COVID-19 pneumonia and stayed in ICU and discharged
Other: Chelsea Critical Care Physical Assessment Tool
Chelsea Critical Care Physical Assessment Tool is a bedside assessment tool firstly reported in 2013 to measure physical morbidity in the critical care population, consisting of 10 items (respiratory function, cough, moving within the bed, supine to sitting on the edge of bed, dynamic sitting, standing balance, sit to stand, transferring from bed to chair, stepping, and grip strength) rated on a 6-point scale from complete dependency (level=0) to independency (level=5). Therefore, the CPAx sum score ranges from 0 (worst condition) to 50 (best functioning/independence)
Chelsea Critical Care Physical Assessment Tool (CPAx)
The CPAx is a bedside assessment tool firstly reported in 2013 to measure physical morbidity in critical care population (12), consisting of 10 items (respiratory function, cough, moving within the bed, supine to sitting on the edge of bed, dynamic sitting, standing balance, sit to stand, transferring from bed to chair, stepping, and grip strength) rated on a 6-point scale from complete dependency (level=0) to independency (level=5), as depicted by Figure 1. Therefore, the CPAx sum score ranges from 0 (worst condition) to 50 (best functioning/independence)
Time frame: Within 48 hours discharge
Barthel Index
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-61 indicate "severe" dependency, 62-90 indicate "moderate" dependency, 91-99 indicates "slight" dependency, and 100 indicate ''full'' independent.
Time frame: Within 48 hours discharge
Katz Index
The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. Clinicians typically use the tool to detect problems in performing activities of daily living and to plan care accordingly. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Time frame: Within 48 hours discharge
Medical Research Council sum score (MRC-SS)
Medical Research Council (MRC)-sumscore evaluates global muscle strength. Manual strength of six muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion) is evaluated on both sides using MRC scale. Summation of scores gives MRC-sumscore, ranging from 0 to 60. This score reliably identifies significant weakness (\< 48) and even better in severe weakness (\< 36) \[4\] which is the main medical interest for treatment in ICU-acquired weakness (ICUAW)
Time frame: Within 48 hours discharge
30 seconds sit to stand
The 30 Second Sit to Stand Test is also known as 30 second chair stand test ( 30CST), is for testing leg strength and endurance in older adults. It is part of the Fullerton Functional Fitness Test Battery. This test was developed to overcome the floor effect of the five or ten repetition sit to stand test in older adults.
Time frame: Within 48 hours discharge
5 times sit to stand test
The five Times Sit to Stand Test (5x Sit-To-Stand Test) commonly abbreviated as 5XSST is used to assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults
Time frame: Within 48 hours discharge
modified Medical Research Council (mMRC) dyspnea scale
The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. Describes baseline dyspnea, but does not accurately quantify response to treatment of chronic obstructive pulmonary disease (COPD).
Time frame: Within 48 hours discharge
Modified Borg scale
Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. It is use in monitoring progress and mode of exercise in cardiac patients as well as in other patient population undergoing rehabilitation and endurance training. Borg RPE scale was developed by Gunnar Borg for rating exertion and breathlessness during physical activity; that is, how hard the activity is as shown by high heart and respiration rate, profuse perspiration and muscle exertion.
Time frame: Within 48 hours discharge
Plan to share: No — The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.
Ran from Feb 2021 to primary completion in May 2021, 3 months.
Of 1,625 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 3 months is below that.
Counting every sponsor, half of 1,750 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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