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

Last updated: November 11, 2024
Sponsor: Unity Health Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

Standard Ventilation Strategy

Respiratory Mechanics

Clinical Study ID

NCT03963622
1765
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 y

  2. Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDScriteria

Exclusion

Exclusion Criteria:

  1. Received continuous mechanical ventilation > 7 days

  2. Known or clinically suspected elevated intracranial pressure (>18mmHg) necessitatingstrict 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 ofcare

  8. Patient is receiving ECMO at time of randomization

Study Design

Total Participants: 740
Treatment Group(s): 2
Primary Treatment: Standard Ventilation Strategy
Phase:
Study Start date:
November 23, 2020
Estimated Completion Date:
March 31, 2026

Study Description

Acute respiratory distress syndrome (ARDS) is a major public health problem affecting approximately 10% of patients in the intensive care unit (ICU) and 23% of all patients on a breathing machine (mechanical ventilator). The short-term mortality of patients with ARDS is approximately 40% and better ventilation of these patients has the greatest potential to improve outcomes.

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.

Connect with a study center

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

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Complejo Médico Policía Federal Argentina Churruca Visca

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Hospital Británico de Buenos Aires

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Sanatorio Anchorena Recoleta

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Sanatorio Mater Dei

    Buenos Aires,
    Argentina

    Active - Recruiting

  • Sanatorio Anchorena San Martín

    San Martín,
    Argentina

    Active - Recruiting

  • St. Michael's Hospital

    Toronto,
    Canada

    Active - Recruiting

  • Toronto General Hospital

    Toronto,
    Canada

    Active - Recruiting

  • Toronto Western Hospital

    Toronto,
    Canada

    Active - Recruiting

  • Pontificia Universidad Católica de Chile

    Santiago de Chile,
    Chile

    Active - Recruiting

  • CHU Amiens-Picardie

    Amiens,
    France

    Active - Recruiting

  • Centre hospitalier universitaire d'Angers

    Angers,
    France

    Active - Recruiting

  • CH Victor Dupouy

    Argenteuil,
    France

    Active - Recruiting

  • CH de Beauvais

    Beauvais,
    France

    Active - Recruiting

  • CHU Bordeaux - Haut Leveque

    Bordeaux,
    France

    Active - Recruiting

  • Hopital de la Cavale Blanche - CHRU Brest

    Brest,
    France

    Active - Recruiting

  • CH de Cholet

    Cholet,
    France

    Active - Recruiting

  • Hopital Intercommunal de Creteil

    Creteil,
    France

    Active - Recruiting

  • CHU Grenoble-Alpes

    Grenoble,
    France

    Active - Recruiting

  • Hopital Roger Salengro - CHU Lille

    Lille,
    France

    Active - Recruiting

  • Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

    Mulhouse,
    France

    Active - Recruiting

  • Hopital de l'Archet 1 - CHU de Nice

    Nice,
    France

    Active - Recruiting

  • Hopital Europeen Georges-Pompidou

    Paris,
    France

    Active - Recruiting

  • CHU de Poitiers - La Miletrie

    Poitiers,
    France

    Active - Recruiting

  • CH Bretagne Atlantique Vannes-Auray

    Vannes,
    France

    Active - Recruiting

  • HIA Robert Picque

    Villenave-d'Ornon,
    France

    Active - Recruiting

  • Arcispedale Sant'Anna

    Ferrara,
    Italy

    Active - Recruiting

  • University of Foggia

    Foggia,
    Italy

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli IRCCS

    Rome,
    Italy

    Active - Recruiting

  • L'Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • Vall d'Hebron University Hospital

    Barcelona,
    Spain

    Active - Recruiting

  • New York University Grossman School of Medicine

    New York, New York 10016
    United States

    Active - Recruiting

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