Quality of Life After COVID-19 Related Acute respIratory Distress Syndrome Among ICU Survivors Patients in Italy: the ODISSEA Study.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Short Form Health Survey 36 [One year after discharge]
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.
Secondary Outcome Measures
- Impact of Event Scale - Revised (IES-R) [One year after discharge]
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.
- Age [One year after discharge]
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
- Gender [One year after discharge]
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
- Scholarship [One year after discharge]
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
- Marital status [One year after discharge]
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
- Steroids [One year after discharge]
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
- Muscle relaxants [One year after discharge]
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
- Renal replacement therapy [One year after discharge]
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
- Tracheostomy [One year after discharge]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anesthesia and Intensive Care, Academic Hospital of Catanzaro | Catanzaro | Calabria | Italy | |
| 2 | Anesthesia, Intensive Care and Pain Therapy, Academic Hospital "Federico II" of Naples | Naples | Campania | Italy | |
| 3 | Anesthesia and Intensive Care, Academic Hospital of Ferrara | Ferrara | Emilia Romagna | Italy | |
| 4 | Anesthesia and Intensive Care 2, Academic Hospital of Parma | Parma | Emilia Romagna | Italy | |
| 5 | Anesthesia and Intensive Care Department, Ravenna Hospital | Ravenna | Emilia Romagna | Italy | |
| 6 | Department of Anesthesia and Intensive Care, Academic Hospital of Udine | Udine | Friuli Venezia Giulia | Italy | 33100 |
| 7 | Anesthesia and Intensive Care 1, Hospital of Trento | Trento | Trentino Alto Adige | Italy | |
| 8 | Anesthesia and Intensive Care 2, Perugia Hospital | Perugia | Umbria | Italy |
Sponsors and Collaborators
- Azienda Sanitaria-Universitaria Integrata di Udine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36.
- Azoulay É, Thiéry G, Chevret S, Moreau D, Darmon M, Bergeron A, Yang K, Meignin V, Ciroldi M, Le Gall JR, Tazi A, Schlemmer B. The prognosis of acute respiratory failure in critically ill cancer patients. Medicine (Baltimore). 2004 Nov;83(6):360-370. doi: 10.1097/01.md.0000145370.63676.fb.
- Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14.
- Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. Erratum in: JAMA. 2021 May 25;325(20):2120.
- Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93.
- Thiéry G, Azoulay E, Darmon M, Ciroldi M, De Miranda S, Lévy V, Fieux F, Moreau D, Le Gall JR, Schlemmer B. Outcome of cancer patients considered for intensive care unit admission: a hospital-wide prospective study. J Clin Oncol. 2005 Jul 1;23(19):4406-13.
- Vetrugno L, Bove T, Orso D, Barbariol F, Bassi F, Boero E, Ferrari G, Kong R. Our Italian experience using lung ultrasound for identification, grading and serial follow-up of severity of lung involvement for management of patients with COVID-19. Echocardiography. 2020 Apr;37(4):625-627. doi: 10.1111/echo.14664. Epub 2020 Apr 15. Review.
- ODISSEA 1.0