Clinical trial NCT04762056: CPAx for Assessing Functional Status of COVID-19 Patients After Intensive Care Unit Discharge
Official title: Validation of Chelsea Physical Assessment Tool (CPAx) in COVID-19 Patients for Assessing Functional Status After Intensive Care Unit Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Intensive Care Unit Syndrome
Covid19
Keywords: post-intensive care syndrome
COVID-19
functional status
coronavirus
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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."

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Chelsea Critical Care Physical Assessment Tool (CPAx)
timeFrame: Within 48 hours discharge
Secondary outcomes:
measure: Barthel Index
timeFrame: Within 48 hours discharge
measure: Katz Index
timeFrame: Within 48 hours discharge
measure: Medical Research Council sum score (MRC-SS)
timeFrame: Within 48 hours discharge
measure: 30 seconds sit to stand
timeFrame: Within 48 hours discharge
measure: 5 times sit to stand test
timeFrame: Within 48 hours discharge
measure: modified Medical Research Council (mMRC) dyspnea scale
timeFrame: Within 48 hours discharge
measure: Modified Borg scale
timeFrame: Within 48 hours discharge
Other outcomes:
Locations:
city: Gazi̇osmanpaşa
country: Turkey
facility: Deniz
state: İstanbul
city: Istanbul
country: Turkey
facility: Koç Univercity Hospital
state: None Selected
Study officials:
affiliation: Gaziosmanpasa Training and Research Hospital Physical and Rehabilitation Department
name: Ebru Yilmaz Yalcinkaya, Prof
role: STUDY_DIRECTOR
affiliation: Koc University School of Medicine Department of Phsical Medicine and Rehabilitation
name: Zeynep Turan, MD
role: STUDY_CHAIR
affiliation: Koc University School of Medicine Department of Phsical Medicine and Rehabilitation
name: Mahir Topaloglu, MD
role: STUDY_CHAIR
affiliation: Koc University School of Medicine Department of Phsical Medicine and Rehabilitation
name: Ozden Ozyemisci Taskiran, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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