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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Covid19; Post Traumatic Stress Disorder

• Study Type: Observational
• Enrollment (Anticipated): 309

Contacts and Locations

• Study Contact: Name: Luigi Vetrugno, MD; Phone Number: + 39 0432559509; Email: luigi.vetrugno@asufc.sanita.fvg.it

Study Locations

• Italy
  • Calabria
    • Catanzaro, Calabria, Italy
      • Not yet recruiting
      • Anesthesia and Intensive Care, Academic Hospital of Catanzaro
      • Contact: Federico Longhini, MD,AP
  • Campania
    • Naples, Campania, Italy
      • Not yet recruiting
      • Anesthesia, Intensive Care and Pain Therapy, Academic Hospital "Federico II" of Naples
      • Contact: Maria Vargas, MD, AP
  • Emilia Romagna
    • Ferrara, Emilia Romagna, Italy
      • Not yet recruiting
      • Anesthesia and Intensive Care, Academic Hospital of Ferrara
      • Contact: Savino Spadaro, MD
    • Parma, Emilia Romagna, Italy
      • Not yet recruiting
      • Anesthesia and Intensive Care 2, Academic Hospital of Parma
      • Contact: Elena Giovanna Bignami, MD,FP
    • Ravenna, Emilia Romagna, Italy
      • Not yet recruiting
      • Anesthesia and Intensive Care Department, Ravenna Hospital
      • Contact: Gianluca Zani, MD
  • Friuli Venezia Giulia
    • Udine, Friuli Venezia Giulia, Italy, 33100
      • Recruiting
      • Department of Anesthesia and Intensive Care, Academic Hospital of Udine
      • Contact: Cristian Deana, MD; Phone Number: +390432552410; Email: cristian.deana@asufc.sanita.fvg.it
      • Principal Investigator: Luigi Vetrugno, MD,AP
      • Sub-Investigator: Amato De Monte, MD
      • Sub-Investigator: Flavio Bassi, MD
      • Sub-Investigator: Tiziana Bove, MD,AP
      • Sub-Investigator: Francesco Meroi, MD
  • Trentino Alto Adige
    • Trento, Trentino Alto Adige, Italy
      • Not yet recruiting
      • Anesthesia and Intensive Care 1, Hospital of Trento
      • Contact: Sergio Lassola, MD
  • Umbria
    • Perugia, Umbria, Italy
      • Not yet recruiting
      • Anesthesia and Intensive Care 2, Perugia Hospital
      • Contact: Edoardo De Robertis, MD,AP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COVID 19 positive patients admitted to the intensive care unit

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 25, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Trauma and Stressor Related Disorders; Lung Injury; Infant, Premature, Diseases; COVID-19; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ODISSEA 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No