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

Active, not recruiting

• Conditions: Weaning Failure; COVID-19; ICU Acquired Weakness
• Interventions: Diagnostic Test: Lung ultrasound; Diagnostic Test: Muscle ultrasound

• Registration Number: NCT04373811
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Study Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-04
• Primary Completion: 2021-07-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung cohort	Lung ultrasound	Lung Ultrasound will be carried out on the first 38 patients of the principal cohort.
Muscle cohort	Muscle ultrasound	Muscle Ultrasound will be carried out on the first 27 patients of the principal cohort.

Primary Outcome Measures

Name	Time	Method
Mean in quality of life score at one year on the Short Form Health Survey (SF-36)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Mean in autonomy score on the Activities Daily Living (ADL) scale	At enrollement and 1 year	Autonomy will be assessed using Activities Daily Living (ADL) scale through a phone call at one year and six months.; ADL scale range from 0 to 6, 6 indicating a better autonomy in activities daily living.
Survival rate	1 year	Survival will be assessed using the death registry query and phone call for vital status recording at six months and one year. Survival rate will be expressed as a survival function using Kaplan Meier method.
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	Lung aeration will be assessed using the Lung Ultrasound Score (LUS). Patient is in semi-recumbent position (30°). 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 will be recorded using a convex probe with a transverse view.; For each thorax area a subscore is calculated: 0 = normal profil; 1 = multiple and well-defined B-lines; 2 = confluent B-lines; 3 = lung consolidation.; Sum of this subscores allows calculation of the total score out of 60. Presence of pleural thickening and subpleural consolidations will be also recorded.
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	Diaphragm Ultrasound will be used to assess diaphragm thickness and excursion. Patient is in semi-recumbent position (30°). Diaphragm thickness will be performed using intercostal view with a linear probe at the zone of apposition for assessing diaphragm thickness. M-Mode will be used to measure diaphragm thickness at inspiratory time (maximal inspiration) and expiratory time (maximal expiration).; Diaphragm excursion will be measured using a subcostal anterior view with convex probe. Excursion measurement is performed in M-mode as the distance between end-inspiration and end-expiration.; Three measures of both DTF and excursion will performed and the better will be kept.
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	Muscle ultrasound measurements will be performed using a linear probe with a transverse view.; Thickness (cm) of vastus intermedius, rectus femori and tibialis anterior will be measured.
Mean change from baseline in ultrasound muscle cross-sectionnal area	Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU	Muscle ultrasound measurements will be performed using a linear probe with a transverse view.; Cross-sectionnal area (CSA) (cm\^2) of rectus femori and tibialis anterior will be measured.
Mean change from baseline in ultrasound muscle echogeneicity	Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU	Muscle ultrasound measurements will be performed using a linear probe with a transverse view.; Echogeneicity (0 to 255) of rectus femori and tibialis anterior will be measured using Image J software. Penation angle of rectus femori will be assessed.; is used to measure muscle thicknesses, CSA and echogeneicity. Longitudinal view is used to measure angle of pennation.
Mean change from baseline in ultrasound muscle pennation	Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU	Muscle ultrasound measurements will be performed using a linear probe with a longitudinal view.; Penation angle (°) of rectus femori will be assessed.
Mean change from baseline in Medical Research Council (MRC) sum score	Day of enrollement, day 14, day 21, day 28 and day 35 from initial admission in ICU	MRC sum score evaluates strength in three muscle groups of all four limbs. A score between 0 and 5 is assigned to each of them, which renders a maximum total score of 60.
Prevalence of adverse outcomes during early mobilization	From date of enrollement up to 30 days (date of estimated post-ICU discharge)	Number of adverse outcomes during early mobilization of patients will recorded at each mobilization session. Prevalence of adverse outcomes is expressed as the number of adverse outcomes divided by the number of early mobilization sessions.

Trial Locations

Locations (3)

APHP - Hôpital Universitaire Pitié-Salpétrière; 🇫🇷 Paris, Ile De France, France

Centre Hospitalier de Béthune; 🇫🇷 Beuvry, Hauts-de-France, France

Hôpital Forcilles; 🇫🇷 Férolles-Attilly, Ile-de-France, France