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

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ClinicalTrials.gov Identifier: NCT04373811
Recruitment Status : Active, not recruiting
First Posted : May 4, 2020
Last Update Posted : February 18, 2021
Sponsor:
Collaborator:
Hopital Forcilles
Information provided by (Responsible Party):
Groupe Hospitalier Paris 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.


Condition or disease Intervention/treatment
COVID-19 ICU Acquired Weakness Weaning Failure Diagnostic Test: Lung ultrasound Diagnostic Test: Muscle ultrasound

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life and Functional Prognosis at One Year of Patients With COVID-19 Admitted in Post-ICU Setting
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : July 13, 2021
Estimated Study Completion Date : July 13, 2021

Group/Cohort Intervention/treatment
Principal cohort

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


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





Primary Outcome Measures :
  1. Mean in quality of life score at one year on the Short Form Health Survey (SF-36) [ Time Frame: 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 :
  1. Mean in autonomy score on the Activities Daily Living (ADL) scale [ Time Frame: 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.


  2. Survival rate [ Time Frame: 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.

  3. Change from baseline in lung ultrasound aeration score [ Time Frame: 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.


  4. Change from baseline in diaphragm ultrasound thickness and excursion [ Time Frame: 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.


  5. Mean change from baseline in ultrasound muscle thickness [ Time Frame: 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.


  6. Mean change from baseline in ultrasound muscle cross-sectionnal area [ Time Frame: 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.


  7. Mean change from baseline in ultrasound muscle echogeneicity [ Time Frame: 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.


  8. Mean change from baseline in ultrasound muscle pennation [ Time Frame: 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.


  9. Mean change from baseline in Medical Research Council (MRC) sum score [ Time Frame: 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.

  10. Prevalence of adverse outcomes during early mobilization [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373811


Locations
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France
Centre Hospitalier de Béthune
Beuvry, Hauts-de-France, France, 62660
APHP - Hôpital Universitaire Pitié-Salpétrière
Paris, Ile De France, France, 75013
Hôpital Forcilles
Férolles-Attilly, Ile-de-France, France, 77150
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Hopital Forcilles
Investigators
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Principal Investigator: Aymeric LE NEINDRE, PT, PhD Hopital Forcilles
Publications:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT04373811    
Other Study ID Numbers: COVENTRY
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data that support the findings of this study will be openly available in "figshare".
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available at publication of the results.
Access Criteria: Data openly available in a public repository that issues datasets with DOIs

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
COVID-19
ICU
ICUAW
Lung Ultrasound
Muscle Ultrasound
Quality of life
Physiotherapy
Diaphragm Ultrasound