Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03963622

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

Led by Unity Health Toronto · Updated on 2026-01-16

740

Participants Needed

33

Research Sites

301 weeks

Total Duration

On this page

Sponsors

U

Unity Health Toronto

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Moderate or severe ARDS with PaO2/FiO2 ratio of 200 mmHg or less within 48 hours of meeting Berlin ARDS criteria
  • Patients whose PaO2/FiO2 ratio improved above 200 mmHg under prone positioning at protocol start remain eligible
Not Eligible

You will not qualify if you...

  • Received continuous mechanical ventilation for more than 7 days
  • Known or suspected elevated intracranial pressure greater than 18 mmHg requiring strict CO2 control
  • Known pregnancy
  • Presence of broncho-pleural fistula
  • Severe liver disease with Child-Pugh Score of 10 or higher
  • Body mass index (BMI) over 40 kg/m2
  • Anticipation of withdrawal of life support or shift to palliative care
  • Receiving extracorporeal membrane oxygenation (ECMO) at time of randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 33 locations

1

New York University Grossman School of Medicine

New York, New York, United States, 10016

Actively Recruiting

2

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

Buenos Aires, Argentina

Actively Recruiting

3

Complejo Médico Policía Federal Argentina Churruca Visca

Buenos Aires, Argentina

Actively Recruiting

4

Hospital Británico de Buenos Aires

Buenos Aires, Argentina

Actively Recruiting

5

Sanatorio Anchorena Recoleta

Buenos Aires, Argentina

Actively Recruiting

6

Sanatorio Mater Dei

Buenos Aires, Argentina

Actively Recruiting

7

Sanatorio Anchorena San Martín

San Martin, Argentina

Actively Recruiting

8

St. Michael's Hospital

Toronto, Canada

Actively Recruiting

9

Toronto General Hospital

Toronto, Canada

Actively Recruiting

10

Toronto Western Hospital

Toronto, Canada

Actively Recruiting

11

Pontificia Universidad Católica de Chile

Santiago, Chile

Actively Recruiting

12

CHU Amiens-Picardie

Amiens, France

Actively Recruiting

13

Centre hospitalier universitaire d'Angers

Angers, France

Actively Recruiting

14

CH Victor Dupouy

Argenteuil, France

Actively Recruiting

15

CH de Beauvais

Beauvais, France

Actively Recruiting

16

CHU Bordeaux - Haut Leveque

Bordeaux, France

Actively Recruiting

17

Hopital de la Cavale Blanche - CHRU Brest

Brest, France

Actively Recruiting

18

CH de Cholet

Cholet, France

Actively Recruiting

19

Hopital Intercommunal de Creteil

Créteil, France

Actively Recruiting

20

CHU Grenoble-Alpes

Grenoble, France

Actively Recruiting

21

Hopital Roger Salengro - CHU Lille

Lille, France

Actively Recruiting

22

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Mulhouse, France

Actively Recruiting

23

Hopital de l'Archet 1 - CHU de Nice

Nice, France

Actively Recruiting

24

Hopital Europeen Georges-Pompidou

Paris, France

Actively Recruiting

25

CHU de Poitiers - La Miletrie

Poitiers, France

Actively Recruiting

26

CH Bretagne Atlantique Vannes-Auray

Vannes, France

Actively Recruiting

27

HIA Robert Picque

Villenave-d'Ornon, France

Actively Recruiting

28

Arcispedale Sant'Anna

Ferrara, Italy

Actively Recruiting

29

University of Foggia

Foggia, Italy

Actively Recruiting

30

Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Actively Recruiting

31

OLVG

Amsterdam, North Holland, Netherlands

Actively Recruiting

32

L'Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Actively Recruiting

33

Vall d'Hebron University Hospital

Barcelona, Spain

Actively Recruiting

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Research Team

L

Laurent Brochard, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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