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AzTrials

Covid19ODISSEANCT04860687

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

An observational study of Covid19 and Post Traumatic Stress Disorder, run by Azienda Sanitaria-Universitaria Integrata di Udine at 8 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
How many people
309 participants
Where
8 sitesItaly
Study dates
1 Aug 2021to 31 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: COVID 19 positive patients admitted to the intensive care unit

Who may be able to join

  • patients discharged from the intensive care unit after admission for COVID-19 respiratory insufficiency that requested non-invasive or invasive mechanical ventilation

Who cannot join

  • 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 locations and contacts

8 sites in 1 country.

Luigi Vetrugno, MD contact

+ 39 0432559509

luigi.vetrugno@asufc.sanita.fvg.it

8 sites in 1 country

Italy8 sites, 8 recruiting

  • Anesthesia and Intensive Care, Academic Hospital of Catanzaro

    Catanzaro, Calabria

    Federico Longhini, MD,AP

    Not yet recruiting

  • Anesthesia and Intensive Care, Academic Hospital of Ferrara

    Ferrara, Emilia-Romagna

    Savino Spadaro, MD

    Not yet recruiting

  • Anesthesia, Intensive Care and Pain Therapy, Academic Hospital "Federico II" of Naples

    Naples, Campania

    Maria Vargas, MD, AP

    Not yet recruiting

  • Anesthesia and Intensive Care 2, Academic Hospital of Parma

    Parma, Emilia-Romagna

    Elena Giovanna Bignami, MD,FP

    Not yet recruiting

  • Anesthesia and Intensive Care 2, Perugia Hospital

    Perugia, Umbria

    Edoardo De Robertis, MD,AP

    Not yet recruiting

  • Anesthesia and Intensive Care Department, Ravenna Hospital

    Ravenna, Emilia-Romagna

    Gianluca Zani, MD

    Not yet recruiting

  • Anesthesia and Intensive Care 1, Hospital of Trento

    Trento, Trentino-Alto Adige

    Sergio Lassola, MD

    Not yet recruiting

  • Department of Anesthesia and Intensive Care, Academic Hospital of Udine

    Udine, Friuli Venezia Giulia, 33100

    Cristian Deana, MD, +390432552410, cristian.deana@asufc.sanita.fvg.it

    Luigi Vetrugno, MD,AP

    Recruiting

Other trials in Italy

About this study

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.

Read more

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.

Medical subject headings
COVID-19, Stress Disorders, Post-Traumatic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One year after discharge

Secondary outcomes (9)

  1. 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.

    Measured: One year after discharge

  2. 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

    Measured: One year after discharge

  3. 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

    Measured: One year after discharge

  4. 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

    Measured: One year after discharge

  5. 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

    Measured: One year after discharge

  6. 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

    Measured: One year after discharge

  7. 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

    Measured: One year after discharge

  8. 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

    Measured: One year after discharge

  9. 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

    Measured: One year after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2021
  2. Study start1 Aug 2021
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
309 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860687
Sponsor's protocol ID
ODISSEA 1.0
Acronym
ODISSEA
Status last verified
Sep 2021
First submitted
22 Apr 2021
Last updated
7 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32250385

  • 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.

    PubMed 15525848

  • 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.

    PubMed 15994150

  • 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.

    PubMed 32291463

  • 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.

    PubMed 32239532

  • 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.

    PubMed 12594312

  • 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.

    PubMed 9817120

  • Vetrugno L, Sala A, Deana C, Meroi F, Grandesso M, Maggiore SM, Isola M, De Martino M, Restaino S, Vizzielli G, Bove T, Driul L. Quality of life 1 year after hospital discharge in unvaccinated pregnant women with COVID-19 respiratory symptoms: a prospective observational study (ODISSEA-PINK study). Front Med (Lausanne). 2023 Sep 6;10:1225648. doi: 10.3389/fmed.2023.1225648. eCollection 2023.

    PubMed 37746068

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Post Traumatic Stress Disorder, run by Azienda Sanitaria-Universitaria Integrata di Udine at 8 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Luigi Vetrugno, MD (+ 39 0432559509, luigi.vetrugno@asufc.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Form Health Survey 36 (time frame: One year after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04860687, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.

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