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

Covid19 Clinical Trial

— RECOVIDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556513
• Other study ID #: QUENOT 2020
• Status: Completed
• Start date: September 18, 2020
• Est. completion date: September 7, 2022

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: September 7, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• COVID-19
• Covid19
• Functional Recovery
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Paraclinical examination
Respiratory functional tests
• Clinical Examination
Clinical Examination
• Semi-directive interview
By phone
• quality of life questionnaires
SF36, VSRQ, IESR, HADS

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory sequelae 6 months after resuscitation.	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.	Through study completion, an average of 6 months