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

Sponsor

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

Overall Status

Active, not recruiting

CT.gov ID

NCT05650957

Collaborator

Carlos III Health Institute (Other), Hospital Interzonal de Agudos San Martin de La Plata (Other), University of Sao Paulo (Other), Hospital Sirio-Libanes Ensino e Pesquina (Other), National University of Ireland, Galway, Ireland (Other)

7,145

Enrollment

Locations

Anticipated Duration (Months)

1190.8

Patients Per Site

197

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome COVID-19 Pneumonia Mechanical Ventilation Complication

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 Design

Study Type:

Observational

Actual Enrollment :

7145 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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
Incidence of in-hospital mortality [90 days]
Incidence of in-hospital mortality at day 28 and at day 90
ICU length of stay [90 days]
ICU length of stay at day 28 and at day 90
Hospital length of stay [90 days]
Hospital length of stay at day 28 and at day 90

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Age < 18 years
Any form of non-invasive ventilation

Contacts and Locations

Locations

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