PRactice of VENTilation in Patients With ARDS Due to COVID-19 vs Pneumonia (PRoVENT-COP)

July 19, 2023 updated by: Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

PRactice of VENTilation in Patients With ARDS Due to COVID-19 Versus ARDS Due to Other Pulmonary Infections (PRoVENT-COP)

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.

Study Overview

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

Observational

Enrollment (Actual)

7145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • La Plata, Argentina
        • Hospital Interzonal General de Agudos'General Jose de San Martin'
      • São Paulo, Brazil
        • Hospital Sirio-Libanes
      • São Paulo, Brazil
        • Univeristy of São Paulo
      • Galway, Ireland
        • University of Galway
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
      • Madrid, Spain
        • Carlos III health institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of invasive ventilation
Time Frame: Day 1
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).
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator-free days
Time Frame: 28 days
Liberated of invasive ventilation and alive
28 days
Incidence of ICU mortality
Time Frame: 90 days
Incidence of ICU mortality at day 28 and at day 90
90 days
Incidence of in-hospital mortality
Time Frame: 90 days
Incidence of in-hospital mortality at day 28 and at day 90
90 days
ICU length of stay
Time Frame: 90 days
ICU length of stay at day 28 and at day 90
90 days
Hospital length of stay
Time Frame: 90 days
Hospital length of stay at day 28 and at day 90
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: David MP van Meenen, PhD, Amsterdam UMC, location AMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

One year after publication of the main publication

IPD Sharing Access Criteria

All requests must be accompanied by a statistical analysis plan

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

No

Studies a U.S. FDA-regulated device product

No

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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