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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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COVID 19 positive patients admitted to the intensive care unit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Vetrugno, MD | Contact | + 39 0432559509 | luigi.vetrugno@asufc.sanita.fvg.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthesia and Intensive Care, Academic Hospital of Catanzaro | Not yet recruiting | Catanzaro | Calabria | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32250385 | Background | 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. | |
| 15525848 |
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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 |
| Anesthesia, Intensive Care and Pain Therapy, Academic Hospital "Federico II" of Naples | Not yet recruiting | Naples | Campania | Italy |
|
| Anesthesia and Intensive Care, Academic Hospital of Ferrara | Not yet recruiting | Ferrara | Emilia-Romagna | Italy |
|
| Anesthesia and Intensive Care 2, Academic Hospital of Parma | Not yet recruiting | Parma | Emilia-Romagna | Italy |
|
| Anesthesia and Intensive Care Department, Ravenna Hospital | Not yet recruiting | Ravenna | Emilia-Romagna | Italy |
|
| Department of Anesthesia and Intensive Care, Academic Hospital of Udine | Recruiting | Udine | Friuli Venezia Giulia | 33100 | Italy |
|
| Anesthesia and Intensive Care 1, Hospital of Trento | Not yet recruiting | Trento | Trentino-Alto Adige | Italy |
|
| Anesthesia and Intensive Care 2, Perugia Hospital | Not yet recruiting | Perugia | Umbria | Italy |
|
| Background |
| Azoulay E, Thiery 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. |
| 15994150 | Background | Thiery G, Azoulay E, Darmon M, Ciroldi M, De Miranda S, Levy 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. doi: 10.1200/JCO.2005.01.487. |
| 32291463 | Background | 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. No abstract available. |
| 32239532 | Background | 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. |
| 12594312 | Background | 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. doi: 10.1056/NEJMoa022450. |
| 9817120 | Background | Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8. |
| 37746068 | Derived | Vetrugno L, Sala A, Deana C, Meroi F, Grandesso M, Maggiore SM, Isola M, De Martino M, Restaino S, Vizzielli G, Bove T, Driul L. Quality of life 1 year after hospital discharge in unvaccinated pregnant women with COVID-19 respiratory symptoms: a prospective observational study (ODISSEA-PINK study). Front Med (Lausanne). 2023 Sep 6;10:1225648. doi: 10.3389/fmed.2023.1225648. eCollection 2023. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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