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

Completed

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

• Registration Number: NCT05650957
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-14
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7145

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characteristics of invasive ventilation	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).

Secondary Outcome Measures

Name	Time	Method
Incidence of in-hospital mortality	90 days	Incidence of in-hospital mortality at day 28 and at day 90
Hospital length of stay	90 days	Hospital length of stay at day 28 and at day 90
ICU length of stay	90 days	ICU length of stay at day 28 and at day 90
Ventilator-free days	28 days	Liberated of invasive ventilation and alive
Incidence of ICU mortality	90 days	Incidence of ICU mortality at day 28 and at day 90

Trial Locations

Locations (6)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); 🇳🇱 Amsterdam, Netherlands

Hospital Sirio-Libanes; 🇧🇷 São Paulo, Brazil

Hospital Interzonal General de Agudos'General Jose de San Martin'; 🇦🇷 La Plata, Argentina

University of Galway; 🇮🇪 Galway, Ireland

Carlos III health institute; 🇪🇸 Madrid, Spain

Univeristy of São Paulo; 🇧🇷 São Paulo, Brazil