PRactice of VENTilation in Patients With ARDS Due to COVID-19 vs Pneumonia

NCT ID: NCT05650957

Last Updated: 2024-07-03

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

7145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Distress Syndrome COVID-19 Pneumonia Mechanical Ventilation Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

COVID-19 ARDS

To be included in this analysis the cause for ARDS was COVID-19 and meeting all aspects of the Berlin definition.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Carlos III Health Institute

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role collaborator

Amsterdam UMC

OTHER

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Marcus J. Schultz

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David MP van Meenen, PhD

Role: STUDY_CHAIR

Amsterdam UMC, location AMC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Interzonal General de Agudos'General Jose de San Martin'

La Plata, , Argentina

Site Status

Hospital Sirio-Libanes

São Paulo, , Brazil

Site Status

Univeristy of São Paulo

São Paulo, , Brazil

Site Status

University of Galway

Galway, , Ireland

Site Status

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam, , Netherlands

Site Status

Carlos III health institute

Madrid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina Brazil Ireland Netherlands Spain

References

Explore related publications, articles, or registry entries linked to this study.

van der Ven FLIM, Blok SG, Azevedo LC, Bellani G, Botta M, Estenssoro E, Fan E, Ferreira JC, Laffey JG, Martin-Loeches I, Motos A, Pham T, Penuelas O, Pesenti A, Pisani L, Neto AS, Schultz MJ, Torres A, Tsonas AM, Paulus F, van Meenen DMP; and for the ERICC-; LUNG SAFE-; PRoVENT-COVID-; EPICCoV-; CIBERESUCICOVID-; SATI-COVID-19-investigators. Epidemiology, ventilation management and outcomes of COVID-19 ARDS patients versus patients with ARDS due to pneumonia in the Pre-COVID era. Respir Res. 2024 Aug 17;25(1):312. doi: 10.1186/s12931-024-02910-2.

Reference Type DERIVED
PMID: 39153979 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AUMC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.