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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
Must not have
Known or clinically suspected elevated intracranial pressure (>18mmHg) necessitating strict control of PaCO2
Broncho-pleural fistula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1-7, 14, 21, 28
Awards & highlights
Summary
This trial tests if adjusting ventilator settings based on lung measurements can reduce deaths in ARDS patients, including those with COVID-19. The goal is to provide better breathing support without causing more lung damage.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need specific treatment to manage high pressure in my brain.
Select...
I have a connection between my lung and chest wall.
Select...
I do not have severe liver disease.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
All-cause 60-day mortality
Secondary study objectives
Duration of ICU and hospital stay
Duration of ventilation
Mortality at ICU discharge, 28 days, and hospital discharge
+2 moreOther study objectives
The change in biomarker expression
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.
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
556 Previous Clinical Trials
453,666 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,379 Previous Clinical Trials
26,513,272 Total Patients Enrolled
University of TorontoOTHER
708 Previous Clinical Trials
1,021,187 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.
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