Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
CAVIARDS
1 other identifier
interventional
740
8 countries
33
Brief 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.).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedStudy Start
First participant enrolled
November 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
January 16, 2026
January 1, 2026
5.5 years
May 6, 2019
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause 60-day mortality
The lack of an appropriate surrogate endpoint, and the high baseline mortality rate mandate a multicentre RCT to determine the mortality effects of setting the ventilator based on recruitability and effort compared with conventional ventilation.
60 days
Secondary Outcomes (5)
Duration of ventilation
May exceed 60 days
Duration of ICU and hospital stay
May exceed 60 days
Number of patients with organ dysfunction
Day 1-7, 14, 21, 28
Number of patients with barotrauma
Up to 60 days
Mortality at ICU discharge, 28 days, and hospital discharge
Up to date of ICU discharge, 28 days, and hospital discharge
Other Outcomes (1)
The change in biomarker expression
Baseline, 24 and 72 hours
Study Arms (2)
Control
ACTIVE COMPARATORStandard ventilation strategy.
Respiratory Mechanics
EXPERIMENTALThe goal of this arm is to individualize tidal volume (VT) and PEEP according to respiratory mechanics.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 y
- Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria (Patients who were eligible at the time of screening and whose PaO2/FiO2 became \> 200 mm Hg under prone positioning when starting the protocol remained eligible)
You may not qualify if:
- Received continuous mechanical ventilation \> 7 days
- Known or clinically suspected elevated intracranial pressure (\>18mmHg) necessitating strict control of PaCO2
- Known pregnancy
- Broncho-pleural fistula
- Severe liver disease (Child-Pugh Score ≥ 10)
- BMI \>40kg/m2
- Anticipating withdrawal of life support and/or shift to palliation as the goal of care
- Patient is receiving ECMO at time of randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontocollaborator
- Applied Health Research Centrecollaborator
- Unity Health Torontolead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (33)
New York University Grossman School of Medicine
New York, New York, 10016, 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
Related Publications (2)
Coudroy R, Telias I, Jonkman A, Thille AW, Diehl JL, Peron N, Ko M, Bourion AA, Tiribelli N, Fredes S, Gutierrez M, Manchado Bruno A, Vasquez DN, Pratto RA, Plotnikow GA, Bianchini F, Accoce M, Dorado J, Spadaro S, La Rosa R, Prat G, Bailly P, Delbove A, Pacheco-Reyes A, Roca O, Kuteifan K, Rouze A, Grieco DL, Izura-Gomez M, Mancebo J, Sigaud F, Terzi N, Saccheri C, Dellamonica J, Richecoeur J, Setten M, Rauseo M, Beloncle F, Repusseau B, Roze H, Tran-Van D, Damiani F, Slama M, Kaufman DA, Maraffi T, Goligher EC, Plantefeve G, Determann R, Giamou M, Pham T, Del Sorbo L, Keown-Stoneman CDG, Nisenbaum R, Thorpe K, Piraino T, Chen L, Juni P, Ferguson ND, Slutsky AS, Brochard L; CAVIARDS study group. Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial. BMJ Open. 2026 Feb 23;16(2):e115775. doi: 10.1136/bmjopen-2025-115775.
PMID: 41730551DERIVEDVillalba DS, Matesa A, Boni S, Gutierrez FJ, Moracci R, Plotnikow GA. Impact of High-Flow Nasal Cannula Oxygen Therapy on the Pressure of the Airway System in Humans. Respir Care. 2025 Jan;70(1):10-16. doi: 10.1089/respcare.12082.
PMID: 39964860DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Brochard, MD
Unity Health Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 24, 2019
Study Start
November 23, 2020
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
The final anonymized trial dataset will be available on reasonable written request to the principal investigator one year after publication of the main manuscript.