Clinical trial NCT05650957: PRactice of VENTilation in Patients With ARDS Due to COVID-19 vs Pneumonia
Official title: PRactice of VENTilation in Patients With ARDS Due to COVID-19 Versus ARDS Due to Other Pulmonary Infections (PRoVENT-COP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
COVID-19
Pneumonia
Mechanical Ventilation Complication
Keywords: Mechanical ventilation
Acute Respiratory Distress Syndrome
Ventilation practice
Pulmonary infection
COVID-19
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
name: University of Sao Paulo
name: National University of Ireland, Galway, Ireland
name: Amsterdam UMC
First posted: 2022-12-14
Enrollment: 7145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult critically ill patients receiving invasive ventilation due to ARDS caused by COVID -19 or a pulmonary infection from another origen.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Cause for ARDS is COVID -19 (confirmed with polymerase chain reaction (PCR) and/or presence of typical abnormalities on chest computer tomography (CT) and/or X-ray) or a pulmonary infection from another origen
2. Meeting a Berlin criteria for ARDS
3. Invasive ventilation

Exclusion Criteria:

1. Age \< 18 years
2. Any form of non-invasive ventilation

Primary outcomes:
measure: Characteristics of invasive ventilation
timeFrame: Day 1
Secondary outcomes:
measure: Ventilator-free days
timeFrame: 28 days
measure: Incidence of ICU mortality
timeFrame: 90 days
measure: Incidence of in-hospital mortality
timeFrame: 90 days
measure: ICU length of stay
timeFrame: 90 days
measure: Hospital length of stay
timeFrame: 90 days
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Hospital Interzonal General de Agudos'General Jose de San Martin'
city: São Paulo
country: Brazil
facility: Hospital Sirio-Libanes
city: São Paulo
country: Brazil
facility: Univeristy of São Paulo
city: Galway
country: Ireland
facility: University of Galway
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
city: Madrid
country: Spain
facility: Carlos III health institute
Study officials:
affiliation: Amsterdam UMC, location AMC
name: David MP van Meenen, PhD
role: STUDY_CHAIR
References: