FreeO2 for Chronic Obstructive Pulmonary Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new oxygen therapy device, FreeO2, to determine if it can improve breathing in people with COPD (a lung disease that causes breathing trouble) and those recovering from weight-loss surgery. Researchers aim to discover whether this device, when combined with other breathing support methods, can stabilize oxygen levels and prevent dangerous fluctuations. Suitable participants include those with COPD who experience sudden worsening of symptoms and have trouble breathing, or those who have undergone bariatric surgery and use CPAP (a breathing support device for sleep apnea). As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could enhance breathing support options.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the FreeO2 device combined with noninvasive respiratory support technique is safe for COPD and postoperative bariatric surgery patients?
Research has shown that the FreeO2 device is generally safe for patients. It includes a safety feature that alerts users to issues with the oxygen supply. Studies have found that using FreeO2 can reduce the risk of breathing problems and shorten hospital stays for people with COPD (chronic obstructive pulmonary disease).
Nasal High Flow Oxygen Therapy (NHFOT) is also well-tolerated. One study found that it eases breathing difficulties without causing serious side effects. NHFOT has effectively reduced respiratory distress and lowered the risk of treatment failure.
In summary, both the FreeO2 device and NHFOT are considered safe and effective for addressing breathing issues in patients with COPD or those recovering from surgery.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative oxygen delivery methods for Chronic Obstructive Pulmonary Disease (COPD) patients, specifically during acute exacerbations. Traditional treatments often involve standard oxygen therapy or CPAP, but this study looks at methods like FreeO2 technology and Nasal High Flow Oxygen therapy, which offer more precise control over oxygen levels and can adjust automatically based on a patient's needs. This precision aims to improve respiratory function more effectively and potentially reduce the risk of respiratory acidosis. By comparing these methods, researchers hope to find out which offers the most significant benefits for maintaining stable oxygen levels and overall patient outcomes in acute settings.
What evidence suggests that the FreeO2 device is effective for COPD?
Research shows that the FreeO2 device helps maintain steady blood oxygen levels in people with chronic obstructive pulmonary disease (COPD). Studies have found that FreeO2 better maintains the right oxygen levels and reduces episodes of low oxygen (desaturations) and too much oxygen (hyperoxia) compared to manual methods. This could help patients breathe easier and feel more comfortable. In this trial, some participants will receive FreeO2, while others will receive Nasal High Flow Oxygen Therapy (NHFOT). NHFOT appears to improve oxygen exchange in the lungs and reduce the effort required for breathing. It also enhances the quality of life for long-term users compared to regular oxygen therapy. Both treatments are being studied for their potential benefits in managing breathing problems in this trial.35678
Are You a Good Fit for This Trial?
This trial is for COPD patients with respiratory acidosis or low oxygen levels, and those needing CPAP before bariatric surgery due to sleep apnea. It's not suitable for individuals who don't meet the specific breathing and blood gas criteria set by the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oxygen therapy using the FreeO2 device combined with noninvasive ventilation or CPAP
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CPAP
- FreeO2
- Nasal High flow Oxygen therapy
- NIV
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Who Is Running the Clinical Trial?
François Lellouche
Lead Sponsor