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Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study

This study is called the Oxygap2 Study. It looks at how well the small clips (called oximeters) doctors use to measure oxygen in your blood actually work. These oximeters are very important for patients in intensive care who are receiving oxygen, as they help make sure oxygen levels aren't too low (hypoxemia) or too high (hyperoxemia), both of which can be harmful. The study compares readings from common hospital oximeters (like those made by GE, Medtronic, Masimo, and Nonin) with a very precise blood test from an artery to see how accurate they are. The goal is to understand any differences between the oximeters so that doctors can give the best possible oxygen treatment.

At a glance

Status
Recruiting
Sponsor
Laval University
Enrolment target
200
Start
20 Jun 2024
Estimated completion
30 Dec 2026

What is this study about?

When you're really unwell and in intensive care, doctors and nurses need to keep a close eye on your body's vital signs – things like your heart rate, blood pressure, and how much oxygen is in your blood. The oxygen level in your blood is super important. Too little oxygen can be dangerous, but so can too much.

To measure your oxygen, they often use a small clip placed on your finger or earlobe. This clip is called an oximeter, and it estimates the amount of oxygen in your blood (this reading is called SpO2). Doctors rely on these readings to decide how much oxygen to give you. However, it's known that different brands of oximeters might give slightly different readings. This study wants to find out exactly how different they are.

Researchers will compare the readings from these common oximeters with a very accurate measurement taken directly from your blood (called SaO2, which is from an arterial blood gas test). By doing this, they hope to understand the exact accuracy and any quirks of each oximeter. This information will help doctors all over the UK make better decisions about oxygen therapy, ensuring patients get just the right amount of oxygen for their best recovery.

Key takeaways

  • This study compares different oxygen sensors (oximeters) used in hospitals.
  • It aims to improve how doctors give oxygen therapy to very sick patients.
  • The study uses standard hospital equipment and tests you'd already be having.
  • It does not involve new treatments or medications.
  • Findings could lead to better oxygen care for future patients.
  • Participation is voluntary and you can withdraw at any time.

Who may be eligible?

This study is looking for patients of all ages, from newborns to 100-year-olds, who are currently being treated in an Intensive Care Unit (ICU). A key requirement is that a special thin tube (an artery catheter) must already be in place in one of your arteries. This tube is needed to get the very precise oxygen measurements for comparison.

There are certain reasons why you might not be able to join. For example, if the usual oxygen clip on your finger isn't getting a clear signal, or if you're receiving very high doses of certain medications that support your blood pressure. If your nails are painted, or if you have a history of a specific blood condition called methemoglobinemia, or very low iron levels (hemoglobin below 80 g/L), you wouldn't be able to take part.

Also, patients who are in isolation for certain infections (like multi-resistant bacteria, C. Difficile, or SARS-CoV-2), those lying on their front for treatment, or those on a special life support machine called ECMO, would not be suitable for this 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.

  1. Are you 18 years old or older?
  2. Are you currently undergoing treatment in the Intensive Care Unit (ICU)?
  3. Do you already have a small tube (arterial catheter) in an artery for blood tests?
  4. Do you not have painted fingernails or very dark nail polish?
  5. Are you not receiving extremely high doses of certain blood pressure support medicines?
  6. Are you not in isolation for specific infections like COVID-19?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it actually won't involve any extra visits or a long follow-up. The measurements will be taken while you are already in the Intensive Care Unit. The study involves using different brands of oxygen sensors (oximeters) on you at the same time to compare their readings. This will be alongside the standard blood tests you would already be having as part of your normal care, specifically the arterial blood gas test which gets precise oxygen levels. There are no new medications or special treatments involved in this study. The total duration of your participation would be very short, focused on taking these specific measurements during your stay in the ICU.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information learned could help improve oxygen care for future patients. This study uses equipment and tests that are already part of standard care in the ICU, so there are no additional risks beyond those linked with your existing treatment. The main benefit is contributing to better understanding and potentially improving oxygen guidelines for critically ill patients. Remember, participation is completely voluntary, and you have the right to change your mind and withdraw from the study at any time without affecting your medical care.

Locations (3)

  • CHUM
    Verified postcode
    Montreal, Canada· Recruiting
  • CHU Ste-Justine
    Verified postcode
    Montreal, Canada· Not yet recruiting
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec
    Verified postcode
    Québec, Canada· Not yet recruiting

Common questions

What is an oximeter?

It's a small clip, usually on your finger, that measures the oxygen level in your blood without needing to take blood.

Why is this study important?

It helps us understand how accurately different oxygen clips work, so doctors can give the best possible oxygen treatment.

Will I have more blood tests if I join?

No, the study uses blood tests (from an arterial catheter) you would already be having as part of your intensive care treatment.

Will this study change my oxygen treatment?

No, your doctors will continue to give you the oxygen treatment they think is best for you, based on all your vital signs.

Can I stop participating if I want to?

Yes, you can choose to stop being part of the study at any time, and it won't affect your medical care.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Comparison of Pulse Oximetry (SpO2) With Different Oximeters…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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