ARDS stands for Acute Respiratory Distress Syndrome. It is a sudden and serious lung condition where the lungs become inflamed and fill with fluid, making it very hard to breathe on their own. ARDS can be caused by many things, including severe infections like pneumonia or sepsis, injury to the chest, inhaling harmful substances, or other serious illnesses.

Because the lungs can’t get enough oxygen into the blood, most patients with ARDS need a ventilator (breathing machine) to help them breathe while their body and lungs recover. ARDS is a life-threatening condition, and even with excellent medical care, not every patient survives it. Doctors and researchers are still working to find better ways to support the lungs during this critical time — which is the reason studies like PREVENT VILI exist.

A healthcare proxy (sometimes called a legally authorized representative, medical power of attorney, or surrogate decision-maker) is a person who is legally recognized to make medical decisions on someone else’s behalf when that person is unable to make decisions themselves. This is often a spouse, adult child, parent, or other close family member — and in some cases, a person specifically named in an advance directive or power of attorney document.

Patients with ARDS are usually sedated and on a ventilator, which means they cannot speak for themselves or give their own consent to join a study. In this situation, your loved one’s healthcare proxy can be asked to make this decision on their behalf. If your loved one recovers enough to speak for themselves, they will always be kept informed and can choose to continue or withdraw from the study.

A clinical trial is a carefully designed research study that helps doctors learn whether a new treatment or approach works better, the same, or worse than current standard care. Clinical trials are how nearly every treatment used in medicine today was tested and proven safe and effective.

• It is always voluntary. Consent can be withdrawn at any time.
• Standard care continues either way. Declining or leaving the study never affects the quality of care.
• Research is closely regulated and monitored throughout to protect participants.
• You will be told what to expect — purpose, procedures, risks, and benefits — before you decide.

PREVENT VILI is a research study comparing two ways of managing a ventilator for patients with ARDS. Researchers want to find out whether a more personalized approach to ventilator settings helps more patients survive than the usual way ventilators are managed today.

Every patient in the study still receives full, attentive medical care from their treatment team at all times. You can read a more detailed, technical description on our Study Information page.

• Your loved one would be randomly assigned — similar to a coin flip — to one of two ventilator management approaches.
• A thin, soft tube would be placed through the nose or mouth into the esophagus to help measure breathing mechanics.
• The clinical team continues to monitor your loved one closely throughout, exactly as they would with any critically ill patient on a ventilator.
• Study staff continue to follow their recovery after the ventilator period ends.

Because ARDS develops quickly and most patients are sedated, the consent process moves at the pace the situation requires, while making sure you have the information and time you need to decide.

• The ventilator protocol includes strict safety rules for both study groups, so settings never go outside safe, well-established limits.
• An independent Data and Safety Monitoring Board regularly reviews study data and can pause or stop the study if needed.
• The study has been reviewed and approved by an Institutional Review Board (IRB), an independent ethics committee.
• Joining is always voluntary, and you can stop at any time without affecting the care your loved one receives.

Possible benefits: Your loved one may benefit from a ventilator strategy that current research suggests could reduce lung injury and improve survival — though a benefit cannot be guaranteed to any individual patient. Participating also contributes to research that may help future ARDS patients.

Possible risks: As with any ICU care involving mechanical ventilation, there are risks related to the underlying illness and to standard ventilator management. The esophageal catheter carries minor risks similar to other tubes commonly placed in ICU patients. The study team can walk you through the full, detailed list of risks in the official consent form.

• What would change about my loved one’s care if we join, compared to if we don’t?
• What does the consent form say, and can I take time to read it carefully?
• Can we change our minds later, and how would we do that?
• Who can I contact if I have concerns during the study?
• Will we be told which group my loved one was placed in?

Talk to your loved one’s bedside nurse or physician — they can connect you with the study team at your hospital.