What side effects are associated with this type of intervention?

Common treatments for Acute Respiratory Distress Syndrome (ARDS) include mechanical ventilation, prone positioning, neuromuscular blockade, and conservative fluid management. Mechanical ventilation can cause ventilator-associated lung injury if not properly managed. Prone positioning improves oxygenation but may lead to pressure sores and requires careful monitoring. Neuromuscular blockade can enhance oxygenation but risks prolonged neuromuscular weakness. Conservative fluid management helps reduce pulmonary edema but must be balanced to prevent hypotension and organ hypoperfusion.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Acute Respiratory Distress Syndrome (ARDS). Current management strategies primarily involve supportive care, including mechanical ventilation with low tidal volume ventilation (LTVV), prone positioning, and the use of neuromuscular blocking agents in certain cases. Inhaled nitric oxide and prostacyclin analogues like epoprostenol have been used to improve oxygenation, but they have not shown a mortality benefit. Extracorporeal membrane oxygenation (ECMO) is reserved for severe cases refractory to other treatments. The trial 'Ventilator Adjustment Based on Respiratory Mechanics' focuses on optimizing mechanical ventilation, a cornerstone of ARDS management.

What other types of research exist?

Promising novel alternatives for ARDS treatment in 2024 include: 1) Noninvasive ventilatory support techniques, which reduce the need for invasive mechanical ventilation and its associated complications. 2) Advanced recruitment maneuvers to improve lung compliance and prevent derecruitment. 3) Continuous monitoring and titration of PEEP to optimize respiratory mechanics and minimize lung injury. 4) Use of mucoactive agents and secretion clearance techniques to enhance airway clearance and improve respiratory function.

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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

No Placebo-Only Group

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need specific treatment to manage high pressure in my brain.

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I have a connection between my lung and chest wall.

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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

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

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 more

Other study objectives

The change in biomarker expression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

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.

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