Clinical trial NCT04556513: Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status
Official title: Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
ARDS
Functional Recovery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who has been managed in intensive care for covid-19 infection.

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.


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 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)

Primary outcomes:
measure: Respiratory sequelae 6 months after resuscitation.
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
citation: Declercq PL, Fournel I, Demeyere M, Ksiazek E, Meunier-Beillard N, Riviere A, Clarot C, Maizel J, Schnell D, Plantefeve G, Ampere A, Daubin C, Sauneuf B, Kalfon P, Federici L, Redureau E, Bousta M, Lagache L, Vanderlinden T, Nseir S, La Combe B, Bourdin G, Monchi M, Nyunga M, Ramakers M, Oulehri W, Georges H, Salmon Gandonniere C, Badie J, Delbove A, Monnet X, Beduneau G, Artaud-Macari E, Abraham P, Delberghe N, Le Bouar G, Miailhe AF, Hraiech S, Bironneau V, Sedillot N, Hoppe MA, Barbar SD, Calcaianu GD, Dellamonica J, Terzi N, Delpierre C, Gelinotte S, Rigaud JP, Labruyere M, Georges M, Binquet C, Quenot JP; RECOVIDS trial investigators. Influence of socioeconomic status on functional recovery after ARDS caused by SARS-CoV-2: a multicentre, observational study. BMJ Open. 2022 Apr 22;12(4):e057368. doi: 10.1136/bmjopen-2021-057368.