CPAx for Assessing Functional Status of COVID-19 Patients After Intensive Care Unit Discharge

Completed

• Conditions: Post Intensive Care Unit Syndrome; Covid19
• Interventions: Other: Chelsea Critical Care Physical Assessment Tool

• Registration Number: NCT04762056
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-02-22
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Adult patients (patients over 18 years of age)
2. Patients who suffered COVID-19 pneumonia and stayed in ICU and discharged. The patient will be assessed within 48 hours discharge
3. Patients who are able to follow at least 2 of the commands from De Jonghe and colleagues''(8) awakening criteria as follows:

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

1. Patients with previous neurologic impairment
2. Pregnancy
3. Patients whose grip muscle strength cannot be evaluated (dominant extremity amputation etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 patients after ICU discharge	Chelsea Critical Care Physical Assessment Tool	Patients who suffered COVID-19 pneumonia and stayed in ICU and discharged

Primary Outcome Measures

Name	Time	Method
Chelsea Critical Care Physical Assessment Tool (CPAx)	Within 48 hours discharge	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)

Secondary Outcome Measures

Name	Time	Method
Katz Index	Within 48 hours discharge	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.
30 seconds sit to stand	Within 48 hours discharge	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.
5 times sit to stand test	Within 48 hours discharge	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
Medical Research Council sum score (MRC-SS)	Within 48 hours discharge	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)
Modified Borg scale	Within 48 hours discharge	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.
Barthel Index	Within 48 hours discharge	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.
modified Medical Research Council (mMRC) dyspnea scale	Within 48 hours discharge	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).

Trial Locations

Locations (2)

Deniz; 🇹🇷 Gazi̇osmanpaşa, İstanbul, Turkey

Koç Univercity Hospital; 🇹🇷 Istanbul, None Selected, Turkey