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

NCT ID: NCT04762056

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2021-05-30

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.

Conditions

Post Intensive Care Unit Syndrome; Covid19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 patients after ICU discharge

Patients who suffered COVID-19 pneumonia and stayed in ICU and discharged

Chelsea Critical Care Physical Assessment Tool

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ebru Yilmaz Yalcinkaya, Prof

Role: STUDY_DIRECTOR

Gaziosmanpasa Training and Research Hospital Physical and Rehabilitation Department

Zeynep Turan, MD

Role: STUDY_CHAIR

Koc University School of Medicine Department of Phsical Medicine and Rehabilitation

Mahir Topaloglu, MD

Role: STUDY_CHAIR

Koc University School of Medicine Department of Phsical Medicine and Rehabilitation

Ozden Ozyemisci Taskiran, Prof

Role: PRINCIPAL_INVESTIGATOR

Koc University School of Medicine Department of Phsical Medicine and Rehabilitation

Locations

Deniz

Gaziosmanpaşa, Istanbul, Turkey (Türkiye)

Koç Univercity Hospital

Istanbul, None Selected, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Elliott D, Denehy L, Berney S, Alison JA. Assessing physical function and activity for survivors of a critical illness: a review of instruments. Aust Crit Care. 2011 Aug;24(3):155-66. doi: 10.1016/j.aucc.2011.05.002. Epub 2011 Jul 1.

Reference Type: RESULT

PMID: 21723143 (View on PubMed)

Negrini F, Ferrario I, Mazziotti D, Berchicci M, Bonazzi M, de Sire A, Negrini S, Zapparoli L. Neuropsychological Features of Severe Hospitalized Coronavirus Disease 2019 Patients at Clinical Stability and Clues for Postacute Rehabilitation. Arch Phys Med Rehabil. 2021 Jan;102(1):155-158. doi: 10.1016/j.apmr.2020.09.376. Epub 2020 Sep 28.

Reference Type: RESULT

PMID: 32991870 (View on PubMed)

Denehy L, de Morton NA, Skinner EH, Edbrooke L, Haines K, Warrillow S, Berney S. A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther. 2013 Dec;93(12):1636-45. doi: 10.2522/ptj.20120310. Epub 2013 Jul 25.

Reference Type: RESULT

PMID: 23886842 (View on PubMed)

Curci C, Pisano F, Bonacci E, Camozzi DM, Ceravolo C, Bergonzi R, De Franceschi S, Moro P, Guarnieri R, Ferrillo M, Negrini F, de Sire A. Early rehabilitation in post-acute COVID-19 patients: data from an Italian COVID-19 Rehabilitation Unit and proposal of a treatment protocol. Eur J Phys Rehabil Med. 2020 Oct;56(5):633-641. doi: 10.23736/S1973-9087.20.06339-X. Epub 2020 Jul 15.

Reference Type: RESULT

PMID: 32667150 (View on PubMed)

Parry SM, Granger CL, Berney S, Jones J, Beach L, El-Ansary D, Koopman R, Denehy L. Assessment of impairment and activity limitations in the critically ill: a systematic review of measurement instruments and their clinimetric properties. Intensive Care Med. 2015 May;41(5):744-62. doi: 10.1007/s00134-015-3672-x. Epub 2015 Feb 5.

Reference Type: RESULT

PMID: 25652888 (View on PubMed)

Holdar U, Eriksson F, Siesage K, Corner EJ, Ledstrom V, Svensson-Raskh A, Kierkegaard M. Cross-cultural adaptation and inter-rater reliability of the Swedish version of the Chelsea critical care assessment tool (CPAX-Swe) in critically ill patients. Disabil Rehabil. 2021 Jun;43(11):1600-1604. doi: 10.1080/09638288.2019.1668971. Epub 2019 Sep 26.

Reference Type: RESULT

PMID: 31558043 (View on PubMed)

Nordon-Craft A, Schenkman M, Edbrooke L, Malone DJ, Moss M, Denehy L. The physical function intensive care test: implementation in survivors of critical illness. Phys Ther. 2014 Oct;94(10):1499-507. doi: 10.2522/ptj.20130451. Epub 2014 May 8.

Reference Type: RESULT

PMID: 24810863 (View on PubMed)

De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

Reference Type: RESULT

PMID: 12472328 (View on PubMed)

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id