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

A

Azienda Sanitaria-Universitaria Integrata di Udine

Status

Unknown

Conditions

Post Traumatic Stress Disorder
Quality of Life
Covid19

Study type

Observational

Funder types

Other

Identifiers

NCT04860687
ODISSEA 1.0

Details and patient eligibility

About

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.

Enrollment

309 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

8

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Central trial contact

Luigi Vetrugno, MD

Data sourced from clinicaltrials.gov

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