- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05650957
PRactice of VENTilation in Patients With ARDS Due to COVID-19 vs Pneumonia (PRoVENT-COP)
PRactice of VENTilation in Patients With ARDS Due to COVID-19 Versus ARDS Due to Other Pulmonary Infections (PRoVENT-COP)
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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La Plata, Argentina
- Hospital Interzonal General de Agudos'General Jose de San Martin'
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São Paulo, Brazil
- Hospital Sirio-Libanes
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São Paulo, Brazil
- Univeristy of São Paulo
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Galway, Ireland
- University of Galway
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Amsterdam, Netherlands
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Madrid, Spain
- Carlos III health institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- Meeting a Berlin criteria for ARDS
- Invasive ventilation
Exclusion Criteria:
- Age < 18 years
- Any form of non-invasive ventilation
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Non-COVID-19 ARDS
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.
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COVID-19 ARDS
To be included in this analysis the cause for ARDS was COVID-19 and meeting all aspects of the Berlin definition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Characteristics of invasive ventilation
Time Frame: Day 1
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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).
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Ventilator-free days
Time Frame: 28 days
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Liberated of invasive ventilation and alive
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28 days
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Incidence of ICU mortality
Time Frame: 90 days
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Incidence of ICU mortality at day 28 and at day 90
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90 days
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Incidence of in-hospital mortality
Time Frame: 90 days
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Incidence of in-hospital mortality at day 28 and at day 90
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90 days
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ICU length of stay
Time Frame: 90 days
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ICU length of stay at day 28 and at day 90
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90 days
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Hospital length of stay
Time Frame: 90 days
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Hospital length of stay at day 28 and at day 90
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90 days
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: David MP van Meenen, PhD, Amsterdam UMC, location AMC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Lung Diseases
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Pneumonia
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
Other Study ID Numbers
- AUMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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