Clinical trial NCT04860687: Quality of Life After COVID-19 Related Acute respIratory Distress Syndrome Among ICU Survivors Patients in Italy: the ODISSEA Study.
Official title: Quality of Life After COVID-19 Related Acute respIratory Distress Syndrome Among ICU Survivors Patients in Italy: the ODISSEA Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Post Traumatic Stress Disorder
Quality of Life
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID 19 positive patients admitted to the intensive care unit

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.


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

Primary outcomes:
measure: Short Form Health Survey 36
timeFrame: One year after discharge
Secondary outcomes:
measure: Impact of Event Scale - Revised (IES-R)
timeFrame: One year after discharge
measure: Age
timeFrame: One year after discharge
measure: Gender
timeFrame: One year after discharge
measure: Scholarship
timeFrame: One year after discharge
measure: Marital status
timeFrame: One year after discharge
measure: Steroids
timeFrame: One year after discharge
measure: Muscle relaxants
timeFrame: One year after discharge
measure: Renal replacement therapy
timeFrame: One year after discharge
measure: Tracheostomy
timeFrame: One year after discharge
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Anesthesia and Intensive Care, Academic Hospital of Catanzaro
state: Calabria
city: Naples
country: Italy
facility: Anesthesia, Intensive Care and Pain Therapy, Academic Hospital "Federico II" of Naples
state: Campania
city: Ferrara
country: Italy
facility: Anesthesia and Intensive Care, Academic Hospital of Ferrara
state: Emilia Romagna
city: Parma
country: Italy
facility: Anesthesia and Intensive Care 2, Academic Hospital of Parma
state: Emilia Romagna
city: Ravenna
country: Italy
facility: Anesthesia and Intensive Care Department, Ravenna Hospital
state: Emilia Romagna
city: Udine
country: Italy
facility: Department of Anesthesia and Intensive Care, Academic Hospital of Udine
state: Friuli Venezia Giulia
city: Trento
country: Italy
facility: Anesthesia and Intensive Care 1, Hospital of Trento
state: Trentino Alto Adige
city: Perugia
country: Italy
facility: Anesthesia and Intensive Care 2, Perugia Hospital
state: Umbria
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.