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Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
Sponsor: Unity Health Toronto
Summary
This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS). The CAVIARDS study is also a basket trial; a basket trial design examines a single intervention in multiple disease populations. CAVIARDS consists of an identical 2-arm mechanical ventilation protocol implemented in two different study populations (COVID-19 and non-COVID-19 patients). As per a typical basket trial design, the operational structure of both the COVID-19 substudy (CAVIARDS-19) and non-COVID-19 substudy (CAVIARDS-all) is shared (recruitment, procedures, data collection, analysis, management, etc.).
Official title: Careful Ventilation in Acute Respiratory Distress Syndrome
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
740
Start Date
2020-11-23
Completion Date
2026-09
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (33)
New York University Grossman School of Medicine
New York, New York, United States
Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC)
Buenos Aires, Argentina
Complejo Médico Policía Federal Argentina Churruca Visca
Buenos Aires, Argentina
Hospital Británico de Buenos Aires
Buenos Aires, Argentina
Sanatorio Anchorena Recoleta
Buenos Aires, Argentina
Sanatorio Mater Dei
Buenos Aires, Argentina
Sanatorio Anchorena San Martín
San Martín, Argentina
St. Michael's Hospital
Toronto, Canada
Toronto General Hospital
Toronto, Canada
Toronto Western Hospital
Toronto, Canada
Pontificia Universidad Católica de Chile
Santiago, Chile
CHU Amiens-Picardie
Amiens, France
Centre hospitalier universitaire d'Angers
Angers, France
CH Victor Dupouy
Argenteuil, France
CH de Beauvais
Beauvais, France
CHU Bordeaux - Haut Leveque
Bordeaux, France
Hopital de la Cavale Blanche - CHRU Brest
Brest, France
CH de Cholet
Cholet, France
Hopital Intercommunal de Creteil
Créteil, France
CHU Grenoble-Alpes
Grenoble, France
Hopital Roger Salengro - CHU Lille
Lille, France
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Mulhouse, France
Hopital de l'Archet 1 - CHU de Nice
Nice, France
Hopital Europeen Georges-Pompidou
Paris, France
CHU de Poitiers - La Miletrie
Poitiers, France
CH Bretagne Atlantique Vannes-Auray
Vannes, France
HIA Robert Picque
Villenave-d'Ornon, France
Arcispedale Sant'Anna
Ferrara, Italy
University of Foggia
Foggia, Italy
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
OLVG
Amsterdam, North Holland, Netherlands
L'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Vall d'Hebron University Hospital
Barcelona, Spain