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

Covid19 Clinical Trial

— ODISSEA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860687
• Other study ID #: ODISSEA 1.0
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: Luigi Vetrugno, MD
• Phone: + 39 0432559509
• Email: luigi.vetrugno[@]asufc.sanita.fvg.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 309
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Covid19
• Post Traumatic Stress Disorder
• Quality of Life
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
Italy	Anesthesia and Intensive Care, Academic Hospital of Catanzaro	Catanzaro	Calabria
Italy	Anesthesia and Intensive Care, Academic Hospital of Ferrara	Ferrara	Emilia Romagna
Italy	Anesthesia, Intensive Care and Pain Therapy, Academic Hospital "Federico II" of Naples	Naples	Campania
Italy	Anesthesia and Intensive Care 2, Academic Hospital of Parma	Parma	Emilia Romagna
Italy	Anesthesia and Intensive Care 2, Perugia Hospital	Perugia	Umbria
Italy	Anesthesia and Intensive Care Department, Ravenna Hospital	Ravenna	Emilia Romagna
Italy	Anesthesia and Intensive Care 1, Hospital of Trento	Trento	Trentino Alto Adige
Italy	Department of Anesthesia and Intensive Care, Academic Hospital of Udine	Udine	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. — View Citation

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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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