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Respiratory Mechanics
Ventilation Strategy for Acute Respiratory Distress Syndrome (CAVIARDS Trial)
N/A
Recruiting
Led By Laurent Brochard, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 y
Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1-7, 14, 21, 28
Awards & highlights
CAVIARDS Trial Summary
This trial is examining if setting the ventilator based on measurements of respiratory mechanics can help to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS), in both COVID-19 and non-COVID-19 patients.
Who is the study for?
This trial is for adults over 18 with moderate or severe ARDS, a type of lung failure, diagnosed within the past 48 hours. It's not for those with severe liver disease, on ECMO at randomization time, ventilated >7 days already, pregnant women, suspected high brain pressure needing PaCO2 control, broncho-pleural fistula cases, BMI >40kg/m2 or if life support withdrawal is anticipated.Check my eligibility
What is being tested?
The CAVIARDS study tests whether setting ventilators based on respiratory mechanics can lower the chance of dying by day 60 in ARDS patients. This includes both COVID-19 and non-COVID-19 patients in an adaptive randomized controlled trial comparing standard ventilation strategies to this new approach.See study design
What are the potential side effects?
While specific side effects are not listed here due to the nature of mechanical ventilation interventions rather than drug treatments; potential risks may include lung injury from overdistension (barotrauma), low blood oxygen levels (hypoxemia), or other complications related to mechanical ventilation.
CAVIARDS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have severe breathing problems and was diagnosed with ARDS recently.
CAVIARDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1-7, 14, 21, 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-7, 14, 21, 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause 60-day mortality
Secondary outcome measures
Duration of ICU and hospital stay
Duration of ventilation
Mortality at ICU discharge, 28 days, and hospital discharge
+2 moreOther outcome measures
The change in biomarker expression
CAVIARDS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Respiratory MechanicsExperimental Treatment1 Intervention
The goal of this arm is to individualize tidal volume (VT) and PEEP according to respiratory mechanics.
Group II: ControlActive Control1 Intervention
Standard ventilation strategy.
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,025 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,452,677 Total Patients Enrolled
University of TorontoOTHER
690 Previous Clinical Trials
1,018,903 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need specific treatment to manage high pressure in my brain.I am 18 years old or older.I have a connection between my lung and chest wall.You have been on a breathing machine for more than 7 days without a break.You have a body mass index (BMI) higher than 40.You are expected to stop life support and focus on comfort care.I have severe breathing problems and was diagnosed with ARDS recently.You are currently receiving ECMO treatment when the trial starts.I do not have severe liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Respiratory Mechanics
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being accepted for this clinical exploration?
"This trial is still open for recruitment, as evidenced on clinicaltrials.gov, where it was initially published at the end of November 2020 and edited most recently in late June 2022."
Answered by AI
How many participants are being accepted into the experiment?
"Indeed, the information available on clinicaltrials.gov demonstrates that this medical experiment is actively recruiting patients. Initially posted in November of 2020 and recently amended at the end of June 2022, it seeks to enrol 740 individuals in 4 distinct sites."
Answered by AI
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