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

Completed

• Conditions: Covid19; Functional Recovery; ARDS
• Interventions: Other: Paraclinical examination; Other: Clinical Examination; Other: Semi-directive interview; Other: quality of life questionnaires

• Registration Number: NCT04556513
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-16
• Study Start: 2020-09-18
• Study First Submitted QC: 2020-09-18
• Study First Posted: 2020-09-21
• Primary Completion: 2022-01-20
• Study Completion: 2022-09-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 543

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Respiratory sequelae 6 months after resuscitation.	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.

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France