RecruitingNAINTERVENTIONAL

Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery

Doctors are studying a new piece of equipment called FreeO2 that helps manage oxygen levels for patients. This research is for two groups of people: those with a lung condition called COPD who are having a flare-up, and people recovering from weight-loss surgery. The FreeO2 device works with breathing support machines like NIV or CPAP. The main goal is to see if FreeO2 can do a better job at keeping a patient's oxygen levels steady. This is important because having oxygen levels that are too low or too high can cause problems. By keeping oxygen levels in the right range, the study hopes to improve patient care and recovery.

At a glance

Status

Recruiting

Phase

Sponsor

François Lellouche

Enrolment target

Start

28 Oct 2019

Estimated completion

01 Jun 2028

COPD Exacerbation Oxygen Toxicity Abdominal Obesity Surgery

What is this study about?

This study is investigating a new device called FreeO2 that helps manage oxygen for patients. It's designed to work alongside common breathing support equipment like NIV (Non-Invasive Ventilation) and CPAP (Continuous Positive Airway Pressure). The research focuses on two main groups of patients: individuals experiencing a flare-up of their COPD (a long-term lung condition) and those who have recently had weight-loss surgery (bariatric surgery).

The main aim is to find out if using the FreeO2 device helps patients spend more time with their oxygen levels exactly where they need to be. Keeping oxygen levels in a very specific range is important; if they're too low, it can mean you're not getting enough air, and if they're too high, it can sometimes be harmful. For COPD patients, the study also looks at carbon dioxide levels, which are crucial for this condition.

Ultimately, researchers want to see if this new device can improve how patients receive oxygen therapy, making it more precise and safer. This could lead to better recovery for those after surgery and better management of breathing difficulties for people with COPD.

Key takeaways

This study uses a new device called FreeO2 to fine-tune oxygen delivery.
It aims to keep oxygen levels just right for patients with COPD or after weight-loss surgery.
The goal is to avoid oxygen levels that are too low or too high.
It works with common breathing support machines like NIV and CPAP.
The study hopes to make oxygen therapy more precise and safer.

Who may be eligible?

For people with COPD, you might be able to join if you're experiencing a flare-up that causes your blood to be a bit too acidic, or if your oxygen levels are generally low. You would typically be using oxygen therapy or a high-flow nasal cannula at the time. Your doctor will check specific blood test results to confirm if you meet these criteria.

If you're having weight-loss surgery, you might be suitable for the study if you already use a CPAP machine before your operation because of a sleep condition called obstructive sleep apnea. This also applies if you have a condition called obesity hypoventilation syndrome alongside your sleep apnea.

You would not be able to join if you are under 18 or pregnant. Other reasons to not be included are if you have severe breathing problems needing immediate intensive care, have difficulty following instructions due to confusion, have certain medical conditions that make breathing support unsafe (like a collapsed lung), or if your blood pressure is very unstable. Of course, refusing to take part would also mean you wouldn't be in 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 18 years old or older?
Are you currently having a flare-up of your COPD *or* are you having weight-loss surgery and use CPAP for sleep apnea?
Are you able to provide consent and understand the study information?
Do you *not* have any severe breathing problems that need immediate intensive care?
Are you *not* pregnant?
Is your blood pressure generally stable?

Answer every question to see your result.

What does participation involve?

This study will involve a small number of patients, with only five people from each group (COPD and weight-loss surgery). If you agree to take part, the main thing that will happen is that you'll receive your oxygen therapy through the FreeO2 device connected to your usual breathing support (NIV, CPAP, or high-flow nasal cannula). Researchers will be closely monitoring your oxygen and carbon dioxide levels to see how well the device is working. There isn't any medication involved specifically for the study. The exact duration of your participation would depend on your hospital stay and recovery, but it primarily involves the period when you're receiving oxygen support with the device.

Potential risks and benefits

Participating in this study might offer the benefit of receiving oxygen therapy that is more precisely controlled, potentially leading to better and safer oxygen levels during your recovery or COPD flare-up. However, it's important to know that new devices are always being tested, and we can't guarantee individual benefits. The risks involved are generally low, as the FreeO2 device works with equipment you might already be using, but there's always a chance of unexpected issues with new technology. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Institut universitaire de Cardiologie et de Pneumologie - Université Laval
Verified postcode
Québec, Canada· Recruiting

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that causes breathing difficulties, usually due to long-term damage to the lungs.

What is bariatric surgery?

Bariatric surgery is a type of operation that helps people who are very overweight lose weight, often by making changes to the stomach or digestive system.

What does 'oxygen saturation target' mean?

This refers to the ideal range for the amount of oxygen in your blood. Doctors try to keep it within certain limits to ensure you get enough oxygen without getting too much.

Is the FreeO2 device an approved treatment?

This study is part of research to evaluate the FreeO2 device. It's being tested to see how well it works and if it can improve current ways of managing oxygen.

What is NIV and CPAP?

NIV (Non-Invasive Ventilation) and CPAP (Continuous Positive Airway Pressure) are types of machines that help people breathe more easily, often delivering air or oxygen through a mask.

How to find out more

François Lellouche, MD, PhD

francois.lellouche@criucpq.ulaval.ca 418-656-8711 Official trial record

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