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

Description

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

ARDS

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Study Overview

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Study Details

Study overview

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.).

Careful Ventilation in Acute Respiratory Distress Syndrome

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

Condition
ARDS
Intervention / Treatment

-

Contacts and Locations

New York

New York University Grossman School of Medicine, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥ 18 y
  • 2. Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria
  • 1. Received continuous mechanical ventilation \> 7 days
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Unity Health Toronto,

Laurent Brochard, MD, PRINCIPAL_INVESTIGATOR, Unity Health Toronto

Study Record Dates

2026-03