Active not recruitingOBSERVATIONAL

Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome

This study is investigating a severe lung condition called Acute Respiratory Distress Syndrome (ARDS). ARDS makes it very hard to breathe and often requires machines to help. We believe there are different types of ARDS, which we call 'phenotypes,' and that knowing which type a patient has could help doctors provide better care. This study uses a new, quick test called a 'point-of-care assay' to identify these different types. We want to see if patients identified with a 'hyper-inflammatory' type of ARDS have more severe outcomes than those with a 'hypo-inflammatory' type. The main goal is to understand if this new test can accurately identify these types and how that relates to a patient's recovery. We're also checking how practical this test is to use in NHS intensive care units.

At a glance

Status

Active not recruiting

Sponsor

Queen's University, Belfast

Enrolment target

480

Start

22 Nov 2019

Estimated completion

27 Feb 2026

Acute Respiratory Distress Syndrome (ARDS)

What is this study about?

Imagine your lungs are like sponges, and sometimes they get very stiff and filled with fluid, making it incredibly hard to breathe. This is what happens in a serious condition called Acute Respiratory Distress Syndrome, or ARDS. People with ARDS often need a breathing machine to help them get enough oxygen.

Even though doctors have learned a lot about ARDS, it's still a very serious illness, and sadly, many people don't recover fully. One big challenge is that ARDS isn't always the same for everyone. It seems there might be different 'types' of ARDS, like different kinds of flu, even though they all cause similar breathing problems. If doctors could quickly tell which 'type' of ARDS a patient has, they might be able to offer more tailored and effective treatments.

This study is trying to do just that. We're using a special new test, called a 'point-of-care assay,' that can be done quickly right at the patient's bedside. This test helps identify whether a patient has a 'hyper-inflammatory' type of ARDS (which means their body is reacting with a very strong inflammatory response) or a 'hypo-inflammatory' type. The main goal is to see if knowing this information early on can help predict how well a patient might recover and if it helps doctors make better treatment decisions. We also want to see if this new test can be easily used in busy NHS intensive care units.

Key takeaways

This study focuses on a serious lung condition called ARDS.
It aims to identify different 'types' of ARDS using a new quick test.
Understanding these types may help predict recovery and improve future treatments.
Participation involves using your medical data collected during routine care.
No new medicines or procedures are given in this study.
The goal is to improve care for future ARDS patients.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with ARDS. To be included, patients must currently be using a breathing machine or a special high-flow oxygen device to help them breathe.

The diagnosis of ARDS needs to meet specific medical guidelines, meaning it started recently (within 7 days of an event like an injury or infection) and the patient has specific breathing difficulties and changes seen on lung scans that are not caused by heart problems.

There are also some reasons why a patient might not be able to join. This includes if they are under 18, if more than two days have passed since their ARDS started, or if they are already on a particular kind of advanced life support called ECMO. Patients whose doctors believe they may sadly not survive for long, or who have already decided they don't wish to be resuscitated (unless it's an advance directive), also wouldn't be able to participate. We would also not include patients who decline to take part or who are prisoners.

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.

Am I 18 years old or older?
Do I have a recent diagnosis of ARDS?
Am I currently on a breathing machine or high-flow oxygen?
Has less than 48 hours passed since my ARDS started?
Am I not currently receiving advanced life support called ECMO?

Answer every question to see your result.

What does participation involve?

This study primarily involves using a new test to classify your type of ARDS. If you take part, your medical information will be collected as part of your routine care to help us understand how your ARDS type relates to your recovery. Clinical and research staff will not know the results of your specific ARDS type immediately; this information will be kept separate until after the study is complete to avoid influencing your care. You will continue to receive standard care from your medical team as usual, and there are no extra medications or treatments given as part of this study. The study team will follow your progress over time while you are in intensive care to see how your condition changes and recovers.

Potential risks and benefits

There are no direct personal risks involved in participating in this study as it does not involve new medicines or procedures; it uses information gathered as part of your standard care. The main benefit is to help doctors learn more about ARDS, which could lead to better diagnoses and treatments for future patients. While you will receive the best possible standard care, there is no guarantee of direct personal benefit from taking part. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St Vincents Hospital
Verified postcode
Dublin, Ireland
University Hospital Birmingham
Verified postcode
Birmingham, United Kingdom
Royal Blackburn Hospital
Verified postcode
Blackburn, United Kingdom
Royal Liverpool University Hospital
Verified postcode
Liverpool, United Kingdom
University College London
Verified postcode
London, United Kingdom
Guys and St Thomas Hospital
Verified postcode
London, United Kingdom
Kings College Hospital
Verified postcode
London, United Kingdom
Wythenshawe Hospital
Verified postcode
Manchester, United Kingdom
Manchester Royal Infirmary
Verified postcode
Manchester, United Kingdom
Freemans Hospital
Verified postcode
Newcastle upon Tyne, United Kingdom
Nottingham University Hospital
Verified postcode
Nottingham, United Kingdom
Royal Berkshire Hospital
Verified postcode
Reading, United Kingdom

Common questions

What is ARDS?

ARDS is a severe lung condition where fluid builds up in the air sacs, making it very hard to breathe and get enough oxygen.

What is a 'phenotype'?

In this study, a phenotype is like a specific type or pattern of ARDS, which we think may respond differently to treatments.

What is a 'point-of-care assay'?

It's a quick medical test that can be done right at the patient's bedside to get results very fast, rather than sending samples to a lab.

Will I get different treatment if I join?

No, you will receive the same high-quality standard medical care. This study is about helping researchers learn, not changing your immediate treatment.

Is the new test safe?

Yes, the new test itself is safe as it uses existing medical samples or information and does not involve any new procedures or risks to you.