Proof-of-concept Study on Dyspnea Analysis Via GapCO2
This study is for adults who arrive at the emergency department with sudden breathing difficulties. Doctors already take a blood test from an artery to check your blood gases. This study will also use a small sensor, placed on your earlobe or forehead, to measure carbon dioxide through your skin. We want to see if the difference between these two carbon dioxide measurements (what we call GapCO2) can help doctors quickly understand if your breathing problem is due to heart failure or another cause. This could help them decide on the best treatment faster. Your doctors will still provide all the usual care they deem necessary, and this measurement won't change your immediate treatment.
At a glance
What is this study about?
When people suddenly find it hard to breathe, it can be a worrying experience. Doctors in A&E need to quickly figure out what's causing the problem so they can give you the right treatment. Sometimes, breathing difficulties are because of a heart problem, like heart failure. Other times, it's due to something else, like a lung condition.
This study is trying to find a new way to help doctors tell the difference more quickly. They already take a blood test from an artery, usually in your wrist, which gives them important information about your blood. This study will also use a new, non-invasive sensor, a bit like a small sticker, which is placed on your ear or forehead. This sensor measures carbon dioxide through your skin. We want to see if comparing the results from the skin sensor with the results from the arterial blood test (this difference is called GapCO2) can give doctors an early clue about what's causing your breathing problem.
The information from this new measurement won't change how your doctors treat you straight away. They'll still give you all the standard care you need based on their usual assessments. The main goal is to see if this GapCO2 measurement could be a helpful tool for doctors in the future, potentially leading to faster and more accurate diagnoses for people with sudden breathing difficulties.
Key takeaways
- It's about sudden breathing problems in A&E.
- Compares a skin sensor to a blood test result.
- Aims to help doctors find the cause of breathing problems faster.
- Taking part won't change your current medical care.
- The skin sensor is pain-free and non-invasive.
Who may be eligible?
To be part of this study, you need to be at least 18 years old and arrive at the emergency department with sudden breathing difficulties. This means you feel uncomfortable breathing and either your breathing rate is fast (22 breaths per minute or more) or your oxygen levels are a bit low (less than 95%). You also need to have an arterial blood gas test taken as part of your usual care, and be enrolled in the study within an hour of arriving at A&E. Finally, you must agree to take part.
You cannot join the study if you have a fever (37.5°C or higher), or if you've already received certain medications (like water tablets or medicines to widen blood vessels) either before or in the A&E department. You also can't take part if your blood pressure is very low (100 mmHg or less) or if you show signs your body isn't getting enough blood flow. If you're unable to say no to taking part, you also won't be included.
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 18 years old or older?
- Are you in A&E right now with sudden breathing difficulties?
- Will you be having a standard blood test from an artery?
- Have you *not* already had certain heart or water tablets today?
- Is your blood pressure stable (not very low)?
- Are you able to clearly say you want to take part?
What does participation involve?
If you decide to take part, it won't change your standard care. After being settled in the emergency department, a doctor will explain the study to you. If you agree, you'll receive an information sheet and a form to confirm you don't object to participating. Before any treatment begins, a small sensor will be placed on your earlobe. If your ear isn't suitable, it might be placed on your forehead. This sensor will stay on for a period while you're being managed in A&E, measuring your oxygen levels, blood flow, and carbon dioxide through your skin. There will be a short 5-minute wait for the sensor to get accurate readings, and then measurements will continue throughout your time in A&E. All other diagnostic tests and treatments will be provided as your doctors normally would. The results from this sensor won't be used by your treating doctor to make immediate decisions about your care.
Potential risks and benefits
Locations (1)
- Emergency Department Hospital AvicenneVerified postcodeBobigny, France· Recruiting
Common questions
What is 'acute dyspnea'?
It's the medical term for sudden, severe difficulty or discomfort when breathing.
What is an 'arterial blood gas' test?
It's a blood test typically taken from an artery (often in your wrist) to check the levels of oxygen and carbon dioxide in your blood.
Will the sensor hurt?
No, the sensor is like a small sticker placed on your ear or forehead and should not be painful.
Will my doctors change my treatment based on this study?
No, your doctors will continue to provide your usual care and will not use these specific measurements to make immediate treatment decisions for you.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, and it won't affect your medical care.
How to find out more
Judith GORLICKI, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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