Careful Ventilation in Acute Respiratory Distress Syndrome

Who is this study for? Adult patients with Acute Respiratory Distress Syndrome (ARDS)
What treatments are being studied? Respiratory Mechanics Ventilation
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 y

• Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria

Locations
United States
New York
New York University Grossman School of Medicine
RECRUITING
New York
Other Locations
Argentina
Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC)
RECRUITING
Buenos Aires
Complejo Médico Policía Federal Argentina Churruca Visca
RECRUITING
Buenos Aires
Hospital Británico de Buenos Aires
RECRUITING
Buenos Aires
Sanatorio Anchorena Recoleta
RECRUITING
Buenos Aires
Sanatorio Mater Dei
RECRUITING
Buenos Aires
Sanatorio Anchorena San Martín
RECRUITING
San Martín
Canada
St. Michael's Hospital
RECRUITING
Toronto
Toronto General Hospital
RECRUITING
Toronto
Toronto Western Hospital
RECRUITING
Toronto
Chile
Pontificia Universidad Católica de Chile
RECRUITING
Santiago
France
CHU Amiens-Picardie
RECRUITING
Amiens
Centre hospitalier universitaire d'Angers
RECRUITING
Angers
CH Victor Dupouy
RECRUITING
Argenteuil
CH de Beauvais
RECRUITING
Beauvais
CHU Bordeaux - Haut Leveque
RECRUITING
Bordeaux
Hopital de la Cavale Blanche - CHRU Brest
RECRUITING
Brest
CH de Cholet
RECRUITING
Cholet
Hopital Intercommunal de Creteil
RECRUITING
Créteil
CHU Grenoble-Alpes
RECRUITING
Grenoble
Hopital Roger Salengro - CHU Lille
RECRUITING
Lille
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
RECRUITING
Mulhouse
Hopital de l'Archet 1 - CHU de Nice
RECRUITING
Nice
Hopital Europeen Georges-Pompidou
RECRUITING
Paris
CHU de Poitiers - La Miletrie
RECRUITING
Poitiers
CH Bretagne Atlantique Vannes-Auray
RECRUITING
Vannes
HIA Robert Picque
RECRUITING
Villenave-d'ornon
Italy
Arcispedale Sant'Anna
RECRUITING
Ferrara
University of Foggia
RECRUITING
Foggia
Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
Spain
L'Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Vall d'Hebron University Hospital
RECRUITING
Barcelona
Contact Information
Primary
Laurent Brochard, MD
laurent.brochard@unityhealth.to
416-864-6060
Time Frame
Start Date: 2020-11-23
Estimated Completion Date: 2026-03
Participants
Target number of participants: 740
Treatments
Active_comparator: Control
Standard ventilation strategy.
Experimental: Respiratory Mechanics
The goal of this arm is to individualize tidal volume (VT) and PEEP according to respiratory mechanics.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Applied Health Research Centre, University of Toronto
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov