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

COVID-19 Clinical Trial

— PRoVENT-COP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05650957
• Other study ID #: AUMC
• Status: Active, not recruiting
• Start date: August 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7145
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Mechanical Ventilation Complication
• Pneumonia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Carlos III Health Institute, National University of Ireland, Galway, Ireland, University of Sao Paulo

Countries where clinical trial is conducted

Argentina,  Brazil,  Ireland,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (?P); respiratory system compliance (CRS) and mechanical power of ventilation (MP).	Day 1
Secondary	Ventilator-free days	Liberated of invasive ventilation and alive	28 days
Secondary	Incidence of ICU mortality	Incidence of ICU mortality at day 28 and at day 90	90 days
Secondary	Incidence of in-hospital mortality	Incidence of in-hospital mortality at day 28 and at day 90	90 days
Secondary	ICU length of stay	ICU length of stay at day 28 and at day 90	90 days
Secondary	Hospital length of stay	Hospital length of stay at day 28 and at day 90	90 days