An observational study in Acute Respiratory Distress Syndrome, COVID-19 and Pneumonia, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 6 sites in 5 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
This study aims to compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection. The investigators will use individual patient data from four recently published large observational COVID-9 studies, including the 'Practice of VENTilation in COVID-19 patients' (PRoVENT-COVID) study, the 'Epidemiology of COVID-19 patients in the ICU' (EPICCoV) study, the 'SATI-COVID-19 - Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina: a Prospective, Multicenter Cohort Study' and the CIBERESUCICOVID - Personalized Risk and Prognosis Factors and Follow-up at One Year of the Patients Hospitalized in the Spanish Intensive Care Units Infected with COVID -19' study. The investigators will use the individual patient data from ARDS patients with another pulmonary infection from the 'LUNG -SAFE - Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE' study and the 'ERICC - Epidemiology of Respiratory Insufficiency in Critical Care' study.
Early on in the pandemic, it was frequently proposed that ARDS caused by COVID-19 and ARDS caused by another cause were distinct in a number of ways. COVID-19 related ARDS phenotypes have been suggested, based on differences in respiratory system compliance (Crs) and the severity of the hypoxemia. Other reports have even suggested that lung-protective ventilation strategies for patients with ARDS caused by COVID-19 should differ from those used before the pandemic.
The use of low tidal volumes (VT) and prone positioning, which have been shown to be useful in reducing death in patients with ARDS prior to the pandemic, were also shown to be effective in patients with COVID-19 related ARDS, according to several reports. In the discussion of how to ventilate patients with COVID-19 related ARDS, the disagreement over other ventilatory settings, such as the best positive end-expiratory pressure (PEEP) and the use of recruitment manoeuvres, remains remarkably lively.
To compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection, the investigators will use individual patient data from PRoVENT-COVID, EPICCoV, SATI-COVID-19, CIBERESUCICOVID, LUNG-SAFE and ERICC.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 7,145 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Adult critically ill patients receiving invasive ventilation due to ARDS caused by COVID -19 or a pulmonary infection from another origen.
Exclusion Criteria:
To be included in this analysis the cause for ARDS was a pulmonary infection other than COVID-19 and meeting all aspects of the Berlin definition.
To be included in this analysis the cause for ARDS was COVID-19 and meeting all aspects of the Berlin definition.
Characteristics of invasive ventilation
A combination of key ventilation characteristics, including tidal volume (VT); positive end-expiratory pressure (PEEP); fraction inspired oxygen (FiO2); peak pressure (Ppeak) and plateau pressure (Pplat); respiratory rate (RR); driving pressure (ΔP); respiratory system compliance (CRS) and mechanical power of ventilation (MP).
Time frame: Day 1
Ventilator-free days
Liberated of invasive ventilation and alive
Time frame: 28 days
Incidence of ICU mortality
Incidence of ICU mortality at day 28 and at day 90
Time frame: 90 days
Incidence of in-hospital mortality
Incidence of in-hospital mortality at day 28 and at day 90
Time frame: 90 days
ICU length of stay
ICU length of stay at day 28 and at day 90
Time frame: 90 days
Hospital length of stay
Hospital length of stay at day 28 and at day 90
Time frame: 90 days
Plan to share: Yes — The database will be available after publication of the main publication upon reasonable request after consent of the steering committee. Request must be accompanied by a statistical analysis plan.
Supporting information: Study protocol, Sap, Csr, Analytic code
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)