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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04860687
Acronym
ODISSEA
Enrollment
309
Registered
2021-04-27
Start date
2021-08-01
Completion date
2021-12-31
Last updated
2021-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Post Traumatic Stress Disorder, Quality of Life

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.

Interventions

None listed

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Short Form Health Survey 36One year after dischargeEvaluate 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

MeasureTime frameDescription
AgeOne year after dischargeEvaluate 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
GenderOne year after dischargeEvaluate 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
ScholarshipOne year after dischargeEvaluate 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 statusOne year after dischargeEvaluate 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
Impact of Event Scale - Revised (IES-R)One year after dischargeIdentify 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.
Muscle relaxantsOne year after dischargeEvaluate 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 therapyOne year after dischargeEvaluate 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
TracheostomyOne year after dischargeEvaluate 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
SteroidsOne year after dischargeEvaluate 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

Countries

Italy

Contacts

Primary ContactLuigi Vetrugno, MD
luigi.vetrugno@asufc.sanita.fvg.it+ 39 0432559509

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026