Official Title
Quality of Life and Functional Prognosis at One Year of Patients With COVID-19 Admitted in Post-ICU Setting
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 andrequire hospitalization, often in Intensive Care Unit (ICU). Respiratory failure is themain reason for admission in ICU of these patients. Therapeutic strategies implementedfor the management of critically-ill patients may often lead to short-term muscular andfunctional alterations resulting in ICU-Acquired Weakness (ICUAW). These lead tolong-term disabilities expressing trough dependence and quality of life impairment ofsurvivors.The purpose of this study is to assess the quality of life, dependence and survival atone year in patients who survived from COVID-19 in ICU and are admitted in post-ICUsetting for difficult weaning purpose.Ancillary studies aim to assess the course of muscle function (atrophy, structuralmodifications), lung function (loss of aeration) and safety of early mobilization.

Detailed Description

SARS-Cov-2, a virus causing a new infectious disease called COVID-19, has been subject to
numerous publications since its emergence. Almost 20% of people infected with SARS-Cov-2
develop severe to critical symptoms and required hospitalization, often in Intensive Care
Unit (ICU).

Respiratory failure is the main reason for admission in ICU of patients with COVID-19,
which develop an Acute Respiratory Distress Syndrome (ARDS). Respiratory failure may be
associated to liver, renal, coagulation and hemodynamic failure.

Therapeutic strategies implemented for the management of critically-ill patients with
COVID-19 may often lead to short-term muscular and functional alterations resulting in
ICU-Acquired Weakness (ICUAW), as studied in other ICU population.

The muscular and functional impairments of patients are associated to a longer duration
of mechanical ventilation and hospital length of stay and increased mortality. Long-term
impacts are also reported like dependence and quality of life impairment of survivors.

The COVID-19 pandemic currently leads to an increasing number of ICU admission in France
with a high risk of settings saturation. Specialized settings for post-ICU rehabilitation
are preparing to early receive difficult-to-wean patients with ICUAW after admission in
ICU for severe or critical form of COVID-19.

To our best knowledge, no data is obviously available regarding at the future of these
patients in terms of quality of life, dependence or survival. Moreover, no short-term
data are available concerning the course of lung damages and muscle function after ICU
stay. The safety of early mobilization usually delivered in patients admitted to post-ICU
settings has never been assessed in patients with COVID-19.

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 course of muscle function (atrophy, structure
modification), lung function (loss of aeration) and safety of early mobilization.

Active, not recruiting
COVID-19
ICU Acquired Weakness
Weaning Failure

Diagnostic Test: Lung ultrasound

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.

Diagnostic Test: Muscle ultrasound

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.

Eligibility Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Known pregnancy ;

- Person subject to judicial health protection;

- Patient under legal guardianship or curatorship;

- Contraidication for early mobilization;

- Decision to withhold lifesustaining treatment.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 100 Years
Countries
France
Locations

Centre Hospitalier de Béthune
Beuvry, Hauts-de-France, France

APHP - Hôpital Universitaire Pitié-Salpétrière
Paris, Ile De France, France

Hôpital Forcilles
Férolles-Attilly, Ile-de-France, France

Aymeric LE NEINDRE, PT, PhD, Principal Investigator
Hopital Forcilles

Hôpital Forcilles
NCT Number
Keywords
Covid-19
ICU
ICUAW
Lung ultrasound
Muscle Ultrasound
Quality of Life
physiotherapy
Diaphragm Ultrasound
MeSH Terms
COVID-19