Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)

NARecruitingINTERVENTIONAL
Enrollment

740

Participants

Timeline

Start Date

November 23, 2020

Primary Completion Date

November 30, 2025

Study Completion Date

March 31, 2026

Conditions
ARDS
Interventions
OTHER

Respiratory Mechanics

"Different maneuvers based on respiratory mechanics will be assessed at the bedside and will be used to individualize ventilator parameters. Recruitability will be assessed with a one breath decremental PEEP maneuver, and search for airway closure with a low-flow pressure volume or pressure-time curve. If the patient has airway closure, the minimal PEEP will be set at the airway opening pressure to avoid closure. If the patient is considered recruitable, the goal is to set PEEP at or above 15cmH20 to maximize alveolar recruitment, until the plateau pressure reaches the safety limit. Volume control ventilation at 6ml·kg-1 will be used.~Once spontaneous breathing has started, the occlusion pressure (P0.1) will be maintained within targets."

OTHER

Standard Ventilation Strategy

Patients randomized to the control arm will receive standard care. The PEEP is adjusted for oxygenation based on a PEEP-FiO2 table, either the low PEEP-FiO2 or the high PEEP-FiO2 table. Volume targeted ventilation with initial VT 6 mL·kg-1 and Plateau pressure at 30 cmH2O or below, targeting PaO2 60-80 or SpO2 90-95%, adjusted as per the protocol. Pressure-support ventilation is at physician's discretion, but recommended when FiO2 \<60%, and is titrated VT 6-8 mL·kg-1.

Trial Locations (32)

10016

RECRUITING

New York University Grossman School of Medicine, New York

Unknown

RECRUITING

Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC), Buenos Aires

RECRUITING

Complejo Médico Policía Federal Argentina Churruca Visca, Buenos Aires

RECRUITING

Hospital Británico de Buenos Aires, Buenos Aires

RECRUITING

Sanatorio Anchorena Recoleta, Buenos Aires

RECRUITING

Sanatorio Mater Dei, Buenos Aires

RECRUITING

Sanatorio Anchorena San Martín, San Martín

RECRUITING

St. Michael's Hospital, Toronto

RECRUITING

Toronto General Hospital, Toronto

RECRUITING

Toronto Western Hospital, Toronto

RECRUITING

Pontificia Universidad Católica de Chile, Santiago

RECRUITING

CHU Amiens-Picardie, Amiens

RECRUITING

Centre hospitalier universitaire d'Angers, Angers

RECRUITING

CH Victor Dupouy, Argenteuil

RECRUITING

CH de Beauvais, Beauvais

RECRUITING

CHU Bordeaux - Haut Leveque, Bordeaux

RECRUITING

Hopital de la Cavale Blanche - CHRU Brest, Brest

RECRUITING

CH de Cholet, Cholet

RECRUITING

Hopital Intercommunal de Creteil, Créteil

RECRUITING

CHU Grenoble-Alpes, Grenoble

RECRUITING

Hopital Roger Salengro - CHU Lille, Lille

RECRUITING

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Mulhouse

RECRUITING

Hopital de l'Archet 1 - CHU de Nice, Nice

RECRUITING

Hopital Europeen Georges-Pompidou, Paris

RECRUITING

CHU de Poitiers - La Miletrie, Poitiers

RECRUITING

CH Bretagne Atlantique Vannes-Auray, Vannes

RECRUITING

HIA Robert Picque, Villenave-d'Ornon

RECRUITING

Arcispedale Sant'Anna, Ferrara

RECRUITING

University of Foggia, Foggia

RECRUITING

Policlinico Universitario Agostino Gemelli IRCCS, Rome

RECRUITING

L'Hospital de la Santa Creu i Sant Pau, Barcelona

RECRUITING

Vall d'Hebron University Hospital, Barcelona

Sponsors
All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

University of Toronto

OTHER

collaborator

Applied Health Research Centre

OTHER

lead

Unity Health Toronto

OTHER

NCT03963622 - Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19) | Biotech Hunter | Biotech Hunter