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Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status (RECOVIDS)

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Covid19
Functional Recovery
ARDS

Treatments

Other: Semi-directive interview
Other: quality of life questionnaires
Other: Clinical Examination
Other: Paraclinical examination

Study type

Observational

Funder types

Other

Identifiers

NCT04556513
QUENOT 2020

Details and patient eligibility

About

In this study, the investigators are attempting to evaluate the influence of socio-economic factors on the functional recovery (physical and psychological) of patients who developed ARDS after a COVID-19 infection, with the aim of offering personalized medical and social follow-up and support measures in order to avoid medium- and long-term complications, which can result in handicaps, reduced quality of life, and a higher risk of death.

Enrollment

543 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Inpatient in ICU for PCR-proven SARS-VOC-2 infection regardless of specimen type
  • Patient who received a chest CT scan in the initial phase of management (either just before or during hospitalization in the intensive care unit)
  • Patient who has received invasive or non-invasive ventilatory support, or humidified and heated high-flow oxygen (HFO).
  • ARDS meeting the criteria of the 2012 Berlin definition. For patients who have received only HFO, a flow rate at least equal to 50L/minute with a FiO2 strictly greater than 50% with a PaO2/FiO2 ratio less than or equal to 200 will be required for inclusion.
  • Patient who gave oral consent after being informed about the conduct of this study.

Exclusion criteria

  • Patient with limited autonomy prior to hospitalization in limited intensive care unit: walking distance of less than 50 meters, WHO classification status 3 and 4.
  • Patient with a history of chronic respiratory failure as defined by the use of long-term oxygen therapy or non-invasive home ventilation, excluding patients with SAS and/or hypoventilation obesity syndrome.
  • Patient with a history of central or peripheral neurological conditions limiting the patient's motor autonomy and the performance on gait tests or Pulmonary function Tests
  • Patient refusing to participate
  • Patient < 18 years of age
  • Patient not affiliated or not benefiting from national health insurance
  • Patient under guardianship, curatorship or protected adult
  • Patient unable to understand and consent to the research protocol

SECONDARY EXCLUSION CRITERIA

  • Patient not showing up for visit at M6
  • Patients who have not had all the examinations necessary to evaluate the main endpoint (Spirometry, DLCO, TM6 and CT)

Trial design

543 participants in 1 patient group

Patient
Description:
Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection
Treatment:
Other: Paraclinical examination
Other: Clinical Examination
Other: quality of life questionnaires
Other: Semi-directive interview

Trial contacts and locations

1

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Central trial contact

Jean-Pierre QUENOT

Data sourced from clinicaltrials.gov

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