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

NCT05650957 | Completed

• 1 other identifier: AUMC
• Study Type: observational
• Target: 7,145
• Locations: 5 countries
• Sites: 6

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.

Conditions

Acute Respiratory Distress Syndrome; COVID-19; Pneumonia; Mechanical Ventilation Complication

Keywords

Mechanical ventilation; Acute Respiratory Distress Syndrome; Ventilation practice; Pulmonary infection; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 1

Secondary Outcomes (5)

• Ventilator-free days

  28 days

• Incidence of ICU mortality

  90 days

• Incidence of in-hospital mortality

  90 days

• ICU length of stay

  90 days

• Hospital length of stay

  90 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Any form of non-invasive ventilation

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Carlos III Health Institute: collaborator
• University of Sao Paulo: collaborator
• National University of Ireland, Galway, Ireland: collaborator
• Amsterdam UMC: collaborator

Study Sites (6)

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

La Plata, Argentina

Location

Hospital Sirio-Libanes

São Paulo, Brazil

Location

Univeristy of São Paulo

São Paulo, Brazil

Location

University of Galway

Galway, Ireland

Location

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

Amsterdam, Netherlands

Location

Carlos III health institute

Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 39153979 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• David MP van Meenen, PhD

  Amsterdam UMC, location AMC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 14, 2022
• Study Start: August 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: One year after publication of the main publication
• Access Criteria: All requests must be accompanied by a statistical analysis plan

Locations

ES (1); AR (1); IE (1); BR (2); NL (1)