Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome Caused by COVID-19

Study Overview
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Brief Summary
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For the last years, studies have described the  Post-intensive care Syndrome  (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS. The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).

Detailed Description
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Many studies have showed that ARDS survivors keep, even a long time after hospitalization, a functional respiratory disability, resulting on one hand from impaired diffusion of carbon monoxide, and on the other hand from a muscular weakness. Indeed, 67% of patients ventilated more than 10 days have a neuromyopathy whose recovery is uncertain. Beside this, Long-term quality of life is worse than in general population, due in particular to depressive and anxiety disorders such as post-traumatic syndrome disorder with a prevalence around 22% after one year. The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.

Official Title
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Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-CoV-2 (COVID-19)

Conditions
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Human ARDS, Coronavirus Infection

Intervention / Treatment
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* Other: Follow up calls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patient hospitalized in intensive care of the CHU anesthesia-intensive care unit (Rangueil, URM, Neurosurgery) intubated and ventilated supported for an ARDS according to the Berlin criteria (PaO2 / FiO2 ratio <300 mmHg) with an rt-PCR positive to SARS-CoV-2 affiliated to the french social security Exclusion Criteria: minor patient patient under protective measure ARDS in the pandemic context but rt-PCR negative to SARS-CoV-2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Follow up calls|The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care | Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care | month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychological disorders measured by QIDS | psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms | Month 3 | 
| psychological disorders measured by STAI-YA | psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety | Month 3 | 
| psychological disorders measured by QIDS | psychological disorders measured by QIDS : Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms | Month 6 | 
| psychological disorders measured by STAI-YA | psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety | Month 6 | 
| psychological disorders measured by QIDS | psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms | Month 12 | 
| psychological disorders measured by STAI-YA | psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety | Month 12 | 
| quality of life by EQL-5 | Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life) higher score is higher quality of life | Month 3 | 
| quality of life by EQL-5 | Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life | Month 6 | 
| quality of life by EQL-5 | Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life | Month 12 | 
| nutritional status | nutritional status measured by Nutritional Risk Screening 2002 | Month 3 | 
| nutritional status | nutritional status measured by Nutritional Risk Screening 2002 | Month 6 | 
| nutritional status | nutritional status measured by Nutritional Risk Screening 2002 | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-intensive care Syndrome, Acute Respiratory Distress Syndrome, quality of life, intensive care unit, PTSD, follow-up after ICU, COVID-19