RecruitingNAINTERVENTIONAL

Platform of Randomized Adaptive Clinical Trials in Critical Illness

The PRACTICAL study is exploring new treatment approaches for people experiencing severe breathing difficulties, known as acute hypoxemic respiratory failure (AHRF). This condition can be life-threatening and lead to serious long-term health issues. The study aims to find better ways to use breathing machines, advanced life support, and other medicines or devices to help patients get better. It's designed to efficiently test many different strategies at once, helping doctors quickly learn which treatments work best to improve patient outcomes and reduce the risks associated with current care, such as injury from breathing machines.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

6,250

Start

30 Apr 2023

Estimated completion

31 Mar 2027

Respiratory Insufficiency Extracorporeal Membrane Oxygenation Complication Mechanical Ventilation Pressure High

What is this study about?

The PRACTICAL study is a large research effort focused on improving care for people who are critically ill with severe breathing problems. Doctors call this 'acute hypoxemic respiratory failure' (AHRF). Millions of people worldwide suffer from this condition each year, and it can be very serious, sometimes leading to death or long-lasting health issues. When patients need help breathing, often with a breathing machine, there's a risk of harming their lungs or the muscles they use to breathe. This study wants to find new and better ways to help these patients recover. It's looking into different approaches, including how breathing machines are set up, special life support systems, and even new medicines or medical devices.

The study is set up in a clever way, like a 'platform' where many different treatments can be tested at the same time. This means researchers can quickly figure out which treatments are most promising and which aren't as effective. They are studying various treatments across different types of patients – from those who are not on a breathing machine yet, to those who are on one, or even those needing more advanced life support. The goal is to discover safer and more effective ways to manage this serious condition, ultimately helping patients get better and reduce the long-term impact on their health.

Within this large platform, there are smaller, focused studies, called 'domains.' For example, one domain looks at different ways to use breathing machines to protect the lungs and diaphragm (the main breathing muscle). Another domain is investigating specific medicines, like corticosteroids, to see if they can help. By testing these different treatments in a careful, scientific way, the PRACTICAL study aims to find the best strategies to improve survival and recovery for patients with severe breathing difficulties. This research is vital because it could lead to significant improvements in how these very sick patients are cared for.

Key takeaways

PRACTICAL is a major study for critically ill patients with severe breathing issues.
It tests new ways to use breathing machines, advanced life support, and medicines.
The aim is to find better and safer treatments to improve patient recovery and survival.
Different parts of the study focus on specific treatments or patient types.
Participation involves receiving a study treatment alongside standard care, with close monitoring.

Who may be eligible?

To be part of the main PRACTICAL study, you would need to be an adult (18 years or older) and experiencing new or worsening severe breathing problems within the last two weeks. You would also need to be receiving some form of breathing support, such as high-flow oxygen, a breathing machine, or a special type of life support. Your low oxygen levels shouldn't primarily be due to heart failure, too much fluid in your body, or a blood clot in your lungs.

There are also some reasons why you wouldn't be able to join. For example, if doctors expect you to be taken off the breathing machine or leave the intensive care unit (ICU) very soon. You also wouldn't be included if your medical team thinks you are unlikely to survive for more than 24 hours, or if you are already receiving only comfort care.

Some smaller parts of the study, called 'domains,' have their own specific criteria. For instance, one domain looking at advanced life support might only include patients under 70 who have been on a breathing machine for a short time and have very severe breathing difficulties. Your doctors would check all these details carefully to see if you qualify for any part of the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 years or older)?
Have you developed severe breathing problems within the last two weeks?
Are you currently receiving breathing support (like high-flow oxygen or a breathing machine)?
Are your breathing problems not mainly caused by heart failure or a blood clot in your lungs?
Is your medical team planning for you to stay in the ICU for a while?
Are you currently receiving active medical treatment (not just comfort care)?

Answer every question to see your result.

What does participation involve?

If you or your loved one were to take part in the PRACTICAL study, the specific details would depend on which part of the study you join. In general, it would involve receiving one of the study treatments, which could be a specific way of setting up a breathing machine, a particular medicine, or a special type of life support. You would continue to receive the best usual medical care alongside the study treatment.

The study team will carefully monitor your health and recovery. This might involve regular checks of your vital signs, blood tests, and possibly scans or other tests to see how the treatments are affecting you. The duration of your participation would depend on your medical condition and the specific domain you're in, but the research team would explain this fully. There would be no extra hospital visits beyond what is already needed for your care.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of joining PRACTICAL is that you might receive a new treatment or a new way of delivering care that could be more effective than standard approaches, potentially improving your recovery or survival. However, there's also a chance the new treatment might not work as well, or it could have side effects. All treatments, including standard care, carry some risks. The study team will carefully monitor you for any problems. You would be fully informed about what's involved, and it's important to remember that you or your family can choose to leave the study at any time, without it affecting your medical care.

Locations (89)

University of Arizona
Verified postcode
Tucson, United States· Recruiting
University of California Los Angeles (UCLA)
Verified postcode
Los Angeles, United States· Recruiting
University of San Diego (UCSD)
Verified postcode
San Diego, United States· Recruiting
University of California San Francisco
Verified postcode
San Francisco, United States· Recruiting
University of Colorado Hospital
Verified postcode
Aurora, United States· Recruiting
University of Kentucky
Verified postcode
Lexington, United States· Recruiting
University of Maryland Medical System
Verified postcode
Baltimore, United States· Recruiting
The Johns Hopkins Medicine
Verified postcode
Baltimore, United States· Recruiting
VA Ann Arbor Healthcare System
Verified postcode
Ann Arbor, United States· Not yet recruiting
University of Michigan Health
Verified postcode
Ann Arbor, United States· Recruiting
Washington University
Verified postcode
St Louis, United States· Recruiting
University of Nebraska Medical Center
Verified postcode
Omaha, United States· Recruiting

Common questions

What is 'acute hypoxemic respiratory failure'?

It's a serious medical condition where your lungs can't get enough oxygen into your blood, making it very hard to breathe.

What kind of treatments are being tested?

This study looks at different ways to use breathing machines, advanced life support, and certain medicines to help patients breathe better and recover.

Will I get special treatment if I join?

You will receive the best possible medical care. If you join the study, you might also receive one of the new treatments being investigated, in addition to your usual care.

How long does the study last for each patient?

The length of time you'd be involved depends on your condition and which part of the study you qualify for. The research team will provide specific details.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it will not affect the medical care you receive.

How to find out more

Rongyu ( Cindy) Jin

rongyu.jin@uhn.ca 4163404800 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.