Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 543
- 试验地点
- 1
- 主要终点
- Respiratory sequelae 6 months after resuscitation.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Patients who have not had all the examinations necessary to evaluate the main endpoint (Spirometry, DLCO, TM6 and CT)
研究组 & 干预措施
Patient
Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection
干预措施: Paraclinical examination (Other)
Patient
Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection
干预措施: Clinical Examination (Other)
Patient
Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection
干预措施: Semi-directive interview (Other)
Patient
Patient hospitalized in ICU for PCR-proven SARS-COV-2 infection
干预措施: quality of life questionnaires (Other)
结局指标
主要结局
Respiratory sequelae 6 months after resuscitation.
时间窗: 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.
次要结局
未报告次要终点