Clinical trial NCT04373811: One-Year Quality of Life and Functional Prognosis of COVID-19 Patients in Post-ICU Setting
Official title: Quality of Life and Functional Prognosis at One Year of Patients With COVID-19 Admitted in Post-ICU Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
ICU Acquired Weakness
Weaning Failure
Keywords: COVID-19
ICU
ICUAW
Lung Ultrasound
Muscle Ultrasound
Quality of life
Physiotherapy
Diaphragm Ultrasound
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
Collaborators: name: Hopital Forcilles
First posted: 2020-05-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: Mean in quality of life score at one year on the Short Form Health Survey (SF-36)
timeFrame: 1 year
Secondary outcomes:
measure: Mean in autonomy score on the Activities Daily Living (ADL) scale
timeFrame: At enrollement and 1 year
measure: Survival rate
timeFrame: 1 year
measure: Change from baseline in lung ultrasound aeration score
timeFrame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
measure: Change from baseline in diaphragm ultrasound thickness and excursion
timeFrame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
measure: Mean change from baseline in ultrasound muscle thickness
timeFrame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
measure: Mean change from baseline in ultrasound muscle cross-sectionnal area
timeFrame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
measure: Mean change from baseline in ultrasound muscle echogeneicity
timeFrame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
measure: Mean change from baseline in ultrasound muscle pennation
timeFrame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
measure: Mean change from baseline in Medical Research Council (MRC) sum score
timeFrame: Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU
measure: Prevalence of adverse outcomes during early mobilization
timeFrame: From date of enrollement up to 30 days (date of estimated post-ICU discharge)
Other outcomes:
Locations:
city: Beuvry
country: France
facility: Centre Hospitalier de Béthune
state: Hauts-de-France
city: Paris
country: France
facility: APHP - Hôpital Universitaire Pitié-Salpétrière
state: Ile De France
city: Férolles-Attilly
country: France
facility: Hôpital Forcilles
state: Ile-de-France
Study officials:
affiliation: Hopital Forcilles
name: Aymeric LE NEINDRE, PT, PhD
role: PRINCIPAL_INVESTIGATOR
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