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

NCT ID: NCT04860687

Last Updated: 2021-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Covid19 Post Traumatic Stress Disorder Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role lead

Responsible Party

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Luigi Vetrugno

Clinical Professor in Anesthesiology and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anesthesia and Intensive Care, Academic Hospital of Catanzaro

Catanzaro, Calabria, Italy

Site Status NOT_YET_RECRUITING

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

Naples, Campania, Italy

Site Status NOT_YET_RECRUITING

Anesthesia and Intensive Care, Academic Hospital of Ferrara

Ferrara, Emilia-Romagna, Italy

Site Status NOT_YET_RECRUITING

Anesthesia and Intensive Care 2, Academic Hospital of Parma

Parma, Emilia-Romagna, Italy

Site Status NOT_YET_RECRUITING

Anesthesia and Intensive Care Department, Ravenna Hospital

Ravenna, Emilia-Romagna, Italy

Site Status NOT_YET_RECRUITING

Department of Anesthesia and Intensive Care, Academic Hospital of Udine

Udine, Friuli Venezia Giulia, Italy

Site Status RECRUITING

Anesthesia and Intensive Care 1, Hospital of Trento

Trento, Trentino-Alto Adige, Italy

Site Status NOT_YET_RECRUITING

Anesthesia and Intensive Care 2, Perugia Hospital

Perugia, Umbria, Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Luigi Vetrugno, MD

Role: CONTACT

+ 39 0432559509

Facility Contacts

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Federico Longhini, MD,AP

Role: primary

Maria Vargas, MD, AP

Role: primary

Savino Spadaro, MD

Role: primary

Elena Giovanna Bignami, MD,FP

Role: primary

Gianluca Zani, MD

Role: primary

Cristian Deana, MD

Role: primary

+390432552410

Sergio Lassola, MD

Role: primary

Edoardo De Robertis, MD,AP

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32250385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15525848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15994150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32291463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32239532 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12594312 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9817120 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37746068 (View on PubMed)

Other Identifiers

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ODISSEA 1.0

Identifier Type: -

Identifier Source: org_study_id

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