Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
NCT ID: NCT03963622
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
740 participants
INTERVENTIONAL
2020-11-23
2026-09-30
Brief Summary
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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.).
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Detailed Description
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The lungs in patients with ARDS are severely inflamed which reduces lung volume and their ability to stretch, making ventilation difficult and dangerous. However, mechanical ventilation is the mainstay of supportive therapy. Although it is life-saving, it can also can generate secondary injury and inflammation, called ventilator-induced lung injury (VILI). The investigators know that inadequate mechanical ventilation worsens outcomes but are uncertain of the optimal way to manage ventilators at the bedside.
Furthermore, ARDS is challenging because there is no treatment for the alveolar-capillary leak characterizing this syndrome; aside from treating the underlying cause, the only supportive therapy is mechanical ventilation. This is specially the case for COVID-19 induced ARDS. Despite best practices, over-distension of the lung or inappropriate positive end expiratory pressure (PEEP) is common. Finally, once spontaneous breathing has resumed and is assisted by the ventilator, an additional phenomenon occurs, called patient self-inflicted lung injury. The drive for breathing in many patients is stimulated by lung inflammation, and strong breathing efforts can generate high distending pressures, causing lung (and systemic) inflammation and organ damage. Whether the management of COVID-19 induced ARDS should differ from all other ARDS has been debated at length but has no clear response
Recent advances in our understanding of bedside physiology (airway closure, recruitability, lung distension, respiratory drive) can now be applied for an individual titration of mechanical ventilation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Standard ventilation strategy.
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.
Respiratory Mechanics
The goal of this arm is to individualize tidal volume (VT) and PEEP according to respiratory mechanics.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. 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)
Exclusion Criteria
2. Known or clinically suspected elevated intracranial pressure (\>18mmHg) necessitating strict control of PaCO2
3. Known pregnancy
4. Broncho-pleural fistula
5. Severe liver disease (Child-Pugh Score ≥ 10)
6. BMI \>40kg/m2
7. Anticipating withdrawal of life support and/or shift to palliation as the goal of care
8. Patient is receiving ECMO at time of randomization
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University of Toronto
OTHER
Applied Health Research Centre
OTHER
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Laurent Brochard, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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David Kaufman, MD
Role: primary
Pablo Rodriguez, MD
Role: primary
Maria Guaymas, MD
Role: primary
Gustavo Plotnikov, RRT
Role: primary
Daniela Vasquez, MD
Role: primary
Magalí Gutiérrez, MD
Role: primary
Matias Accoce, RRT
Role: primary
Laurent Brochard, MD
Role: primary
Ewan Goligher, MD
Role: primary
Irene Telias, MD
Role: primary
Felipe Damiani, PhD
Role: primary
Michel Slama, MD
Role: primary
Francois Beloncle, MD
Role: primary
Gaetan Plantefeve, MD
Role: primary
Jack Richecoeur, MD
Role: primary
Benjamin Repusseau, MD
Role: primary
Gwenael Prat, MD
Role: primary
Johann Auchabie, MD
Role: primary
Tommaso Maraffi, MD
Role: primary
Florian Sigaud, MD
Role: primary
Saad Nseir, MD
Role: primary
Khaldoun Kuteifan, MD
Role: primary
Jean Dellamonica, MD
Role: primary
Jean-Luc Diehl, MD
Role: primary
Remi Coudroy, MD
Role: primary
Agathe Delbove, MD
Role: primary
David Tran-Van, MD
Role: primary
Savino Spadaro, MD
Role: primary
Michela Rauseo, MD
Role: primary
Domenico L Grieco, MD
Role: primary
Rogier Determann, MD
Role: primary
Marta I Gomez, MD
Role: primary
Andres F Pacheco, MD
Role: primary
References
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Villalba 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.
Related Links
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Study website
Other Identifiers
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1765
Identifier Type: -
Identifier Source: org_study_id
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