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

Fondation Hôpital Saint-Joseph

Status: Active, not recruiting

Conditions: COVID-19; Weaning Failure; ICU Acquired Weakness

Treatments: Diagnostic Test: Muscle ultrasound; Diagnostic Test: Lung ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT04373811

COVENTRY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

65 participants in 3 patient groups

Principal cohort

Description:

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

Description:

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

Treatment:

Diagnostic Test: Lung ultrasound

Muscle cohort

Description:

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

Treatment:

Diagnostic Test: Muscle ultrasound