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Clinical Trials/NCT04556513
NCT04556513
Completed
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country543 target enrollmentSeptember 18, 2020

Overview

Phase
Not Applicable
Intervention
Paraclinical examination
Conditions
Covid19
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
543
Locations
1
Primary Endpoint
Respiratory sequelae 6 months after resuscitation.
Status
Completed
Last Updated
2 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 18, 2020
End Date
September 7, 2022
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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

Arms & Interventions

Patient

Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection

Intervention: Paraclinical examination

Patient

Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection

Intervention: Clinical Examination

Patient

Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection

Intervention: Semi-directive interview

Patient

Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection

Intervention: quality of life questionnaires

Outcomes

Primary Outcomes

Respiratory sequelae 6 months after resuscitation.

Time Frame: Through study completion, an average of 6 months

Defined by the presence of at least one of the following : * An alteration of the alveolar-capillary diffusion of CO \<80% of the predicted normal values * And/or a forced vital capacity \<80% of predicted normal values * and/or O2 desaturation in the 6-minute walk test * And/or pulmonary parenchymatous disease with fibrosis in tomodensitometry.

Study Sites (1)

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