One-Year Quality of Life and Functional Prognosis of COVID-19 Patients in Post-ICU Setting

NCT04373811 | Unknown DMC

• 1 other identifier: COVENTRY
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 3

Brief Summary

The COVID-19 disease has been subject to numerous publications since its emergence. Almost 20% of people suffering from COVID-19 develop severe to critical symptoms and require hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is the main reason for admission in ICU of these patients. Therapeutic strategies implemented for the management of critically-ill patients may often lead to short-term muscular and functional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead to long-term disabilities expressing trough dependence and quality of life impairment of survivors. The purpose of this study is to assess the quality of life, dependence and survival at one year in patients who survived from COVID-19 in ICU and are admitted in post-ICU setting for difficult weaning purpose. Ancillary studies aim to assess the course of muscle function (atrophy, structural modifications), lung function (loss of aeration) and safety of early mobilization.

Conditions

COVID-19; ICU Acquired Weakness; Weaning Failure

Keywords

COVID-19; ICU; ICUAW; Lung Ultrasound; Muscle Ultrasound; Quality of life; Physiotherapy; Diaphragm Ultrasound

Outcome Measures

Primary Outcomes (1)

• Mean in quality of life score at one year on the Short Form Health Survey (SF-36)

  Quality of life will be assessed using Short Form Health Survey (SF-36) through a phone call at one year. SF-36 score range from 0 to 100, 100 indicating a better quality of life.

  1 year

Secondary Outcomes (10)

• Mean in autonomy score on the Activities Daily Living (ADL) scale

  At enrollement and 1 year

• Survival rate

  1 year

• Change from baseline in lung ultrasound aeration score

  Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU

• Change from baseline in diaphragm ultrasound thickness and excursion

  Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU

• Mean change from baseline in ultrasound muscle thickness

  Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU

Study Arms (3)

Principal cohort

Quality of life, autonomy and survival will be assessed at one year on 50 patients. Safety of early mobilization in post-ICU setting and Medical Reasearch Council (MRC) sum score will be assessed during hospitalization.

Lung cohort

Lung Ultrasound will be carried out on the first 38 patients of the principal cohort.

Diagnostic Test: Lung ultrasound

Muscle cohort

Muscle Ultrasound will be carried out on the first 27 patients of the principal cohort.

Diagnostic Test: Muscle ultrasound

Interventions

Lung ultrasound DIAGNOSTIC_TEST

Lung ultrasound will be performed in 12 thorax area: anterior, lateral and posterior, each area divided in superior and inferior area, for each hemithorax. Lung Ultrasound Score (lung aeration) will be recorded using a convex probe with a transverse view. Presence of pleural thickening and subpleural consolidations will be recorded.

Lung cohort

Muscle ultrasound DIAGNOSTIC_TEST

Diaphragm ultrasound will be performed using intercostal view with a linear probe at the zone of apposition for assessing diaphragm thickness and thickening and subcostal anterior view with convex probe to assess diaphragm excursion. Thickness of vastus intermedius, rectus femori and tibialis anterior will be measured using ultrasound linear probe. Cross-sectionnal area and echogeneicity of rectus femori and tibialis anterior will be measured using ultrasound linear probe. Penation angle of rectus femori will be assessed using ultrasound linear probe.

Muscle cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were initially hospitalized in ICU for COVID-19 and then admitted in a post-ICU setting for difficult weaning purpose.

You may qualify if:

• Patient initially hospitalized in ICU for COVID-19;
• Admitted in post-ICU setting (difficult-to-wean unit);
• Age \> 18 years old;
• Membership of a social insurance sheme;
• Medical prescription of early mobilization;
• Patient or relative provides consent.

You may not qualify if:

• Known pregnancy ;
• Person subject to judicial health protection;
• Patient under legal guardianship or curatorship;
• Contraidication for early mobilization;
• Decision to withhold lifesustaining treatment.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Hopital Forcilles: collaborator

Study Sites (3)

Centre Hospitalier de Béthune

Beuvry, Hauts-de-France, 62660, France

Location

Hôpital Forcilles

Férolles-Attilly, Île-de-France Region, 77150, France

Location

APHP - Hôpital Universitaire Pitié-Salpétrière

Paris, Île-de-France Region, 75013, France

Location

Related Publications (11)

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Murthy S, Gomersall CD, Fowler RA. Care for Critically Ill Patients With COVID-19. JAMA. 2020 Apr 21;323(15):1499-1500. doi: 10.1001/jama.2020.3633. No abstract available.

  PMID: 32159735 BACKGROUND

• Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.

  PMID: 24758618 BACKGROUND

• Herridge MS, Moss M, Hough CL, Hopkins RO, Rice TW, Bienvenu OJ, Azoulay E. Recovery and outcomes after the acute respiratory distress syndrome (ARDS) in patients and their family caregivers. Intensive Care Med. 2016 May;42(5):725-738. doi: 10.1007/s00134-016-4321-8. Epub 2016 Mar 30.

  PMID: 27025938 BACKGROUND

• Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.

  PMID: 19633538 BACKGROUND

• Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.

  PMID: 32166346 BACKGROUND

• Parry SM, El-Ansary D, Cartwright MS, Sarwal A, Berney S, Koopman R, Annoni R, Puthucheary Z, Gordon IR, Morris PE, Denehy L. Ultrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function. J Crit Care. 2015 Oct;30(5):1151.e9-14. doi: 10.1016/j.jcrc.2015.05.024. Epub 2015 Jun 3.

  PMID: 26211979 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

  PMID: 14044222 BACKGROUND

• Flaatten H, Kvale R. Survival and quality of life 12 years after ICU. A comparison with the general Norwegian population. Intensive Care Med. 2001 Jun;27(6):1005-11. doi: 10.1007/s001340100960.

  PMID: 11497132 BACKGROUND

• Cartwright MS, Kwayisi G, Griffin LP, Sarwal A, Walker FO, Harris JM, Berry MJ, Chahal PS, Morris PE. Quantitative neuromuscular ultrasound in the intensive care unit. Muscle Nerve. 2013 Feb;47(2):255-9. doi: 10.1002/mus.23525. Epub 2012 Oct 5.

  PMID: 23041986 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Aymeric LE NEINDRE, PT, PhD

  Hopital Forcilles

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 4, 2020
• Study Start: April 16, 2020
• Primary Completion: July 13, 2021
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available at publication of the results.
• Access Criteria: Data openly available in a public repository that issues datasets with DOIs

Locations

FR (3)