Quality of Life After COVID-19 Related Acute respIratory Distress Syndrome Among ICU Survivors Patients in Italy: the ODISSEA Study.

Study Overview
=================
Brief Summary
-----------------
Acute respiratory insufficiency is one of the principal causes of intensive care admission for COVID 19 positive patients. This may determine a variable mortality rate ranging from 25-30%. In these patients, many days of non-invasive or invasive mechanical ventilation are needed to correct severe hypoxemia. Mechanical ventilation is not a direct therapy but allows the clinicians to prolong the time-to-recovery interval necessary for COVID 19 respiratory insufficiency treatment. Long intensive care stay, mechanical ventilation, the use of steroids and sedatives have an impact on the survivors. Previous studies demonstrated that patients admitted to intensive care with non-COVID acute respiratory distress syndrome had a reduction in the quality of life even up to one year after discharge. The aim of this study is to understand if COVID-19 related acute respiratory distress syndrome has a worse impact on the quality of life one year after discharge when compared with non-COVID-19 acute respiratory distress syndrome.

Official Title
-----------------
Quality of Life After COVID-19 Related Acute respIratory Distress Syndrome Among ICU Survivors Patients in Italy: the ODISSEA Study.

Conditions
-----------------
Covid19, Post Traumatic Stress Disorder, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients discharged from the intensive care unit after admission for COVID-19 respiratory insufficiency that requested non-invasive or invasive mechanical ventilation Exclusion Criteria: history of dementia history of behavior disorders pre-existing tracheostomy advanced oncologic disease end-stage-organ disease (dialysis, or enlisted for organ transplantation) no consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form Health Survey 36 | Evaluate the physical abilities of patients discharged from the intensive care unit after admission for COVID-19 respiratory insufficiency. The scale ranges from 0 to 100, where 0 is the worse value and 100 is the best. | One year after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Event Scale - Revised (IES-R) | Identify post traumatic stress disorder in patients discharged from the intensive care unit after admission for COVID-19 respiratory insufficiency. The scale ranges from 0 to 88, where 0 is the best value and 88 the worst. | One year after discharge | 
| Age | Evaluate if there is an association between quality of life measured with Short Form Health Survey 36 scale and Impact of Event Scale - Revised and post traumatic stress disorder with the age of the patients | One year after discharge | 
| Gender | Evaluate if there is an association between quality of life measured with Short Form Health Survey 36 scale and Impact of Event Scale - Revised and post traumatic stress disorder with the gender of the patients | One year after discharge | 
| Scholarship | Evaluate if there is an association between quality of life measured with Short Form Health Survey 36 scale and Impact of Event Scale - Revised and post traumatic stress disorder with the scholarship of the patients | One year after discharge | 
| Marital status | Evaluate if there is an association between quality of life measured with Short Form Health Survey 36 scale and Impact of Event Scale - Revised and post traumatic stress disorder with the marital status of the patients | One year after discharge | 
| Steroids | Evaluate if there is an association between quality of life measured with Short Form Health Survey 36 scale and Impact of Event Scale - Revised and post traumatic stress disorder with the use of steroids | One year after discharge | 
| Muscle relaxants | Evaluate if there is an association between quality of life measured with Short Form Health Survey 36 scale and Impact of Event Scale - Revised and post traumatic stress disorder with the use of muscle relaxants | One year after discharge | 
| Renal replacement therapy | Evaluate if there is an association between quality of life measured with Short Form Health Survey 36 scale and Impact of Event Scale - Revised and post traumatic stress disorder with the use of renal replacement therapy | One year after discharge | 
| Tracheostomy | Evaluate if there is an association between quality of life measured with Short Form Health Survey 36 scale and Impact of Event Scale - Revised and post traumatic stress disorder with tracheostomy | One year after discharge |