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

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ClinicalTrials.gov Identifier: NCT04860687
Recruitment Status : Not yet recruiting
First Posted : April 27, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Luigi Vetrugno, 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.


Condition or disease
Covid19 Post Traumatic Stress Disorder Quality of Life

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Study Type : Observational
Estimated Enrollment : 309 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life After COVID-19 Related Acute respIratory Distress Syndrome Among ICU Survivors Patients in Italy: the ODISSEA Study.
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021





Primary Outcome Measures :
  1. Short Form Health Survey 36 [ Time Frame: 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 :
  1. Impact of Event Scale - Revised (IES-R) [ Time Frame: 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.

  2. Age [ Time Frame: 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

  3. Gender [ Time Frame: 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

  4. Scholarship [ Time Frame: 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

  5. Marital status [ Time Frame: 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

  6. Steroids [ Time Frame: 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

  7. Muscle relaxants [ Time Frame: 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

  8. Renal replacement therapy [ Time Frame: 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

  9. Tracheostomy [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID 19 positive patients admitted to the intensive care unit
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04860687


Contacts
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Contact: Luigi Vetrugno, MD + 39 0432559509 luigi.vetrugno@asufc.sanita.fvg.it

Locations
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Italy
Anesthesia and Intensive Care, Academic Hospital of Catanzaro
Catanzaro, Calabria, Italy
Contact: Federico Longhini, MD,AP         
Anesthesia, Intensive Care and Pain Therapy, Academic Hospital "Federico II" of Naples
Naples, Campania, Italy
Contact: Maria Vargas, MD, AP         
Anesthesia and Intensive Care, Academic Hospital of Ferrara
Ferrara, Emilia Romagna, Italy
Contact: Savino Spadaro, MD         
Anesthesia and Intensive Care 2, Academic Hospital of Parma
Parma, Emilia Romagna, Italy
Contact: Elena Giovanna Bignami, MD,FP         
Anesthesia and Intensive Care Department, Ravenna Hospital
Ravenna, Emilia Romagna, Italy
Contact: Gianluca Zani, MD         
Department of Anesthesia and Intensive Care, Academic Hospital of Udine
Udine, Friuli Venezia Giulia, Italy, 33100
Contact: Cristian Deana, MD    +390432552410    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         
Anesthesia and Intensive Care 1, Hospital of Trento
Trento, Trentino Alto Adige, Italy
Contact: Sergio Lassola, MD         
Anesthesia and Intensive Care 2, Perugia Hospital
Perugia, Umbria, Italy
Contact: Edoardo De Robertis, MD,AP         
Sponsors and Collaborators
Azienda Sanitaria-Universitaria Integrata di Udine
Publications:

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Responsible Party: Luigi Vetrugno, Clinical Professor in Anesthesiology and Intensive Care, Azienda Sanitaria-Universitaria Integrata di Udine
ClinicalTrials.gov Identifier: NCT04860687    
Other Study ID Numbers: ODISSEA 1.0
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury