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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 below
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I am 18 years old or older.
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I have severe breathing problems and was diagnosed with ARDS recently.

CAVIARDS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-7, 14, 21, 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1-7, 14, 21, 28 for reporting.

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 more
Other 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Respiratory Distress Syndrome (ARDS) include mechanical ventilation strategies, fluid management, prone positioning, and pharmacotherapy. Mechanical ventilation, particularly low tidal volume ventilation (LTVV), aims to minimize ventilator-induced lung injury by reducing the stretch on the lungs. Adjusting ventilator settings based on respiratory mechanics, such as recruitability and effort, can optimize lung function and potentially reduce mortality. Conservative fluid management helps reduce pulmonary edema, improving oxygenation and lung function. Prone positioning enhances oxygenation by redistributing lung perfusion and improving ventilation-perfusion matching. Pharmacotherapy, including neuromuscular blockers and pulmonary vasodilators, supports these interventions by reducing oxygen consumption and improving hemodynamics. These treatments are crucial for ARDS patients as they address the underlying pathophysiology of the disease, aiming to improve oxygenation, reduce lung injury, and enhance overall outcomes.
Is permissive hypercapnia a beneficial strategy for pediatric acute lung injury?Pathophysiology and implications for treatment of acute respiratory distress syndrome.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
549 Previous Clinical Trials
450,343 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,354 Previous Clinical Trials
26,459,466 Total Patients Enrolled
University of TorontoOTHER
698 Previous Clinical Trials
1,019,862 Total Patients Enrolled

Media Library

Respiratory Mechanics (Respiratory Mechanics) Clinical Trial Eligibility Overview. Trial Name: NCT03963622 — N/A
Acute Respiratory Distress Syndrome Research Study Groups: Control, Respiratory Mechanics
Acute Respiratory Distress Syndrome Clinical Trial 2023: Respiratory Mechanics Highlights & Side Effects. Trial Name: NCT03963622 — N/A
Respiratory Mechanics (Respiratory Mechanics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03963622 — N/A
~164 spots leftby Jun 2025