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

NCT04762056 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Intensive Care Unit Syndrome; Covid19

Keywords

post-intensive care syndrome; COVID-19; functional status; coronavirus

Outcome Measures

Primary Outcomes (1)

• 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)

  Within 48 hours discharge

Secondary Outcomes (7)

• Barthel Index

  Within 48 hours discharge

• Katz Index

  Within 48 hours discharge

• Medical Research Council sum score (MRC-SS)

  Within 48 hours discharge

• 30 seconds sit to stand

  Within 48 hours discharge

• 5 times sit to stand test

  Within 48 hours discharge

Study Arms (1)

COVID-19 patients after ICU discharge

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

Other: Chelsea Critical Care Physical Assessment Tool

Interventions

Chelsea Critical Care Physical Assessment Tool 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)

COVID-19 patients after ICU discharge

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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."

You may qualify if:

• Adult patients (patients over 18 years of age)
• Patients who suffered COVID-19 pneumonia and stayed in ICU and discharged. The patient will be assessed within 48 hours discharge
• 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."

You may not qualify if:

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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (2)

Deniz

Gaziosmanpaşa, Istanbul, 34255, Turkey (Türkiye)

Location

Koç Univercity Hospital

Istanbul, None Selected, 34010, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 21723143 RESULT

• 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.

  PMID: 32991870 RESULT

• 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.

  PMID: 23886842 RESULT

• 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.

  PMID: 32667150 RESULT

• 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.

  PMID: 25652888 RESULT

• 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.

  PMID: 31558043 RESULT

• 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.

  PMID: 24810863 RESULT

• 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.

  PMID: 12472328 RESULT

MeSH Terms

Conditions

COVID-19; postintensive care syndrome; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ebru Yilmaz Yalcinkaya, Prof

  Gaziosmanpasa Training and Research Hospital Physical and Rehabilitation Department

  STUDY DIRECTOR

• Zeynep Turan, MD

  Koc University School of Medicine Department of Phsical Medicine and Rehabilitation

  STUDY CHAIR

• Mahir Topaloglu, MD

  Koc University School of Medicine Department of Phsical Medicine and Rehabilitation

  STUDY CHAIR

• Ozden Ozyemisci Taskiran, Prof

  Koc University School of Medicine Department of Phsical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: February 22, 2021
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)