NCT04373811

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• ICU Acquired Weakness
• Weaning Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-16
• Primary completion: 2021-07-13
• Completion: 2023-12-31
• First posted: 2020-05-04
• Last updated: 2023-04-27

Locations

3 sites across 1 country: France