Quality of Life After COVID-19 Related Acute respIratory Distress Syndrome Among ICU Survivors Patients in Italy: the ODISSEA Study.
NCT ID: NCT04860687
Last Updated: 2021-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
309 participants
OBSERVATIONAL
2021-08-01
2021-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* history of behavior disorders
* pre-existing tracheostomy
* advanced oncologic disease
* end-stage-organ disease (dialysis, or enlisted for organ transplantation)
* no consent
18 Years
99 Years
ALL
No
Sponsors
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Azienda Sanitaria-Universitaria Integrata di Udine
OTHER
Responsible Party
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Luigi Vetrugno
Clinical Professor in Anesthesiology and Intensive Care
Locations
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Anesthesia and Intensive Care, Academic Hospital of Catanzaro
Catanzaro, Calabria, Italy
Anesthesia, Intensive Care and Pain Therapy, Academic Hospital "Federico II" of Naples
Naples, Campania, Italy
Anesthesia and Intensive Care, Academic Hospital of Ferrara
Ferrara, Emilia-Romagna, Italy
Anesthesia and Intensive Care 2, Academic Hospital of Parma
Parma, Emilia-Romagna, Italy
Anesthesia and Intensive Care Department, Ravenna Hospital
Ravenna, Emilia-Romagna, Italy
Department of Anesthesia and Intensive Care, Academic Hospital of Udine
Udine, Friuli Venezia Giulia, Italy
Anesthesia and Intensive Care 1, Hospital of Trento
Trento, Trentino-Alto Adige, Italy
Anesthesia and Intensive Care 2, Perugia Hospital
Perugia, Umbria, Italy
Countries
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Central Contacts
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Facility Contacts
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Federico Longhini, MD,AP
Role: primary
Maria Vargas, MD, AP
Role: primary
Savino Spadaro, MD
Role: primary
Elena Giovanna Bignami, MD,FP
Role: primary
Gianluca Zani, MD
Role: primary
Sergio Lassola, MD
Role: primary
Edoardo De Robertis, MD,AP
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ODISSEA 1.0
Identifier Type: -
Identifier Source: org_study_id
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