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

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

• Registration Number: NCT04860687
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-25
• Study First Posted: 2021-04-27
• Study Start: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-07
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 309

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short Form Health Survey 36	One year after discharge	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.

Secondary Outcome Measures

Name	Time	Method
Impact of Event Scale - Revised (IES-R)	One year after discharge	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.
Age	One year after discharge	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
Gender	One year after discharge	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
Scholarship	One year after discharge	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
Marital status	One year after discharge	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
Steroids	One year after discharge	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
Muscle relaxants	One year after discharge	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
Renal replacement therapy	One year after discharge	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
Tracheostomy	One year after discharge	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

Trial Locations

Locations (8)

Anesthesia and Intensive Care, Academic Hospital of Catanzaro; 🇮🇹 Catanzaro, Calabria, Italy

Anesthesia and Intensive Care 2, Perugia Hospital; 🇮🇹 Perugia, Umbria, 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 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, Academic Hospital of Ferrara; 🇮🇹 Ferrara, Emilia Romagna, Italy