RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.).

Official Title

Careful Ventilation in Acute Respiratory Distress Syndrome

Quick Facts

Study Start:2020-11-23
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03963622

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 y
  2. 2. Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria
  1. 1. Received continuous mechanical ventilation \> 7 days
  2. 2. Known or clinically suspected elevated intracranial pressure (\>18mmHg) necessitating strict control of PaCO2
  3. 3. Known pregnancy
  4. 4. Broncho-pleural fistula
  5. 5. Severe liver disease (Child-Pugh Score ≥ 10)
  6. 6. BMI \>40kg/m2
  7. 7. Anticipating withdrawal of life support and/or shift to palliation as the goal of care
  8. 8. Patient is receiving ECMO at time of randomization

Contacts and Locations

Study Contact

Laurent Brochard, MD
CONTACT
416-864-6060
laurent.brochard@unityhealth.to

Principal Investigator

Laurent Brochard, MD
PRINCIPAL_INVESTIGATOR
Unity Health Toronto

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Unity Health Toronto

  • Laurent Brochard, MD, PRINCIPAL_INVESTIGATOR, Unity Health Toronto

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-23
Study Completion Date2026-03

Study Record Updates

Study Start Date2020-11-23
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Ventilation
  • ARDS
  • Airway closure
  • Lung recruitment
  • COVID-19
  • Basket trial

Additional Relevant MeSH Terms

  • ARDS