Automated Oxygen Adjustment for COPD Exacerbations

(FreeO2 HypHop Trial)

No longer recruiting at 1 trial location

Overseen By François Lellouche

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Pulmonary embolism, Cardiac edema, Pneumothorax, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new device, called FreeO2, can help people with COPD recover faster during a flare-up. The study will compare the device's automatic oxygen level adjustments to manual adjustments by hospital staff. Individuals with long-standing COPD and worsening breathing symptoms may be suitable candidates for this trial. The goal is to see if the FreeO2 device can reduce hospital stay duration. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance COPD treatment.

Will I have to stop taking my current medications?

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 is safe for automated oxygen adjustment in COPD patients?

Research has shown that the FreeO2 device, which automatically adjusts oxygen levels for COPD patients, is generally safe. In studies, patients with COPD flare-ups in the hospital used the device successfully. A safety feature sounds an alarm if there's an issue with the oxygen supply, offering extra security for users.

Although no serious problems have been directly linked to the FreeO2 device, the limited safety data suggests that potential participants should consult their doctor for personalized advice. Overall, the device aims to make oxygen treatment safer and more efficient for people with breathing difficulties during hospital stays. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Automated Oxygen Adjustment for COPD Exacerbations because it explores a novel method of managing oxygen levels. Unlike standard care, which relies on hospital staff to manually adjust oxygen levels, this trial uses the FreeO2 device to automatically regulate oxygen during hospitalization. This automated approach aims to provide more precise and responsive oxygen delivery, potentially reducing human error and improving patient outcomes. By enhancing the efficiency and accuracy of oxygen titration, this method could revolutionize COPD care and improve recovery times.

What evidence suggests that the FreeO2 device is effective for reducing hospital stay in COPD exacerbations?

Research has shown that the FreeO2 device, which participants in this trial may receive, can help patients with COPD recover faster during flare-ups. One study found that it reduced hospital stays by 29%, from an average of 9.4 days to 6.7 days. This allows patients to recover more quickly and spend less time in the hospital. In this trial, one group will use the FreeO2 device for automated oxygen titration, while another group will have hospital staff manually adjust oxygen levels. Automated adjustment may prove more effective than manual adjustments, potentially leading to quicker recovery and less time away from home. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 40 with COPD or suspected COPD, who have a history of smoking and are experiencing an acute exacerbation. They should need moderate oxygen therapy to maintain certain blood oxygen levels but not require advanced respiratory support like intubation. Patients with conditions such as pulmonary embolism, cardiac issues, pneumothorax, or severe encephalopathy cannot participate.

Inclusion Criteria

I have recently been experiencing worsening shortness of breath.

I am over 40 and have a history of heavy smoking.

I have more mucus, changes in mucus color, or increased difficulty breathing.

Exclusion Criteria

I have chosen not to participate in this trial.

The patient is not able or willing to cooperate with the study requirements.

You have a brain condition with a score higher than 2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either manual or automated oxygen titration during hospitalization

1 week

Inpatient stay

Follow-up

Participants are monitored for hospital readmission and other outcomes after discharge

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FreeO2

Trial Overview The study compares two ways of giving oxygen to patients: one uses the FreeO2 device that automatically adjusts oxygen levels, while the other method involves manual adjustment by healthcare staff. The goal is to see if the FreeO2 can shorten hospital stays for those having a severe flare-up of their COPD.

How Is the Trial Designed?

Group I: Manual Oxygen titration Experimental Treatment 1 Intervention

In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff

Group II: Automated Oxygen titration Experimental Treatment 1 Intervention

In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device

FreeO2 is already approved in European Union, Canada, United Kingdom for the following indications:

Approved in European Union as FreeO2 for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Acute Respiratory Distress Syndrome (ARDS)

Approved in Canada as FreeO2 for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Acute Respiratory Distress Syndrome (ARDS)

Approved in United Kingdom as FreeO2 for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Acute Respiratory Distress Syndrome (ARDS)

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Published Research Related to This Trial

The FreeO2 device effectively maintained patients' oxygen saturation levels within the target range better than manual oxygen titration, leading to reduced instances of severe desaturation and hyperoxia.

Patients using FreeO2 had a shorter average hospital stay (5.8 days) compared to those receiving standard oxygen administration (8.4 days), suggesting that this automated system may improve patient outcomes in respiratory care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial. Lellouche, F., Bouchard, PA., Roberge, M., et al.[2022]

Oxygen therapy is crucial for treating patients with chronic obstructive pulmonary disease (COPD), but improper dosing can lead to serious complications, including increased mortality due to hyperoxia-induced hypercapnia.

New closed-loop oxygen delivery systems that automatically adjust oxygen flow rates show promise in improving patient outcomes by reducing medical errors and healthcare costs, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal oxygen titration in patients with chronic obstructive pulmonary disease: a role for automated oxygen delivery? Lellouche, F., Lipes, J., L'Her, E.[2021]

The innovative FreeO2 system significantly improved oxygen saturation levels in COPD patients during walking, maintaining SpO2 within the target range of 92-96% more effectively than fixed oxygen flow or room air, with only 0.6% of time spent in severe desaturation compared to 23.9% and 52.2% for the other conditions.

Patients using FreeO2 were able to walk 63% further than when breathing room air, indicating that automatic oxygen adjustment not only enhances oxygenation but may also improve exercise tolerance during daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Lellouche, F., L'Her, E., Bouchard, PA., et al.[2022]

In a study involving 12 patients with severe COPD, using automatically titrated oxygen flows (FreeO2) significantly improved endurance walking time and oxygen saturation compared to constant oxygen flow.

The use of FreeO2 did not worsen carbon dioxide levels (pCO2), indicating that it is a safe and effective method for enhancing exercise capacity in patients on long-term oxygen therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Vivodtzev, I., L'Her, E., Vottero, G., et al.[2019]

In a study involving 16 newborn infants on mechanical ventilation, open-loop computer control of inspired oxygen concentration improved oxygen saturation management compared to routine manual adjustments.

The computer-assisted method allowed infants to maintain target oxygen saturation levels more effectively, resulting in less time spent with oxygen saturation below 90%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted adjustment of inspired oxygen concentration improves control of oxygen saturation in newborn infants requiring mechanical ventilation. Sun, Y., Kohane, IS., Stark, AR.[2019]

In a study of 157 hospitalized patients with Acute Exacerbation of COPD, the Automated Oxygen Administration (AOA) device significantly reduced the perception of dyspnea and overall breathing discomfort compared to conventional oxygen therapy, with clinically meaningful improvements in multiple dimensions of dyspnea.

While AOA improved physical symptoms of dyspnea, it did not affect emotional responses or the use of as-needed opioids and benzodiazepines, indicating that while it enhances breathing comfort, it may not address all aspects of patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Oxygen Administration Alleviates Dyspnea in Patients Admitted with Acute Exacerbation of COPD: A Randomized Controlled Trial. Sandau, C., Hansen, EF., Ringbæk, TJ., et al.[2023]

The novel intelligent portable oxygen concentrator (iPOC) can automatically adjust oxygen flow based on real-time monitoring of a patient's physical activity, showing a high accuracy of 91.1% in meeting medical prescriptions.

Compared to conventional portable oxygen concentrators, the iPOC demonstrated improved oxygenation and high user satisfaction, suggesting it could enhance compliance with therapy and encourage physical activity in patients with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Home Oxygen Delivery for Patients with COPD and Respiratory Failure: A New Approach. Sanchez-Morillo, D., Muñoz-Zara, P., Lara-Doña, A., et al.[2020]

In a study involving patients with COPD, the reservoir nasal cannula (RNC) provided a mean arterial hemoglobin oxygen saturation (SpO2) of 91%, compared to 93% with the standard nasal cannula (SNC), indicating that both devices are similarly effective overall.

Despite the slight difference in mean SpO2, the RNC performed better in some patients while worse in others, highlighting the need for individual nighttime oximetry assessments before prescribing oxygen therapy, as daytime measurements may not predict nighttime efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a reservoir nasal cannula (Oxymizer) during sleep in hypoxemic patients with COPD. Hagarty, EM., Skorodin, MS., Stiers, WM., et al.[2019]

Citations

1. oxynov.com oxynov.com/freeo2/

FreeO 2 - OxyNov When tested on patients hospitalized for an exacerbation of COPD, the FreeO2 made it possible to reduce the length of hospital stays by 29%2 (6.7 days compared ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29362258/

Cost-effectiveness of FreeO 2 in patients with chronic ... Objective: Conduct a cost-effectiveness analysis of FreeO2 technology versus manual oxygen-titration technology for patients with chronic ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/8/1/e018835

Cost-effectiveness of FreeO2 in patients with chronic ... A study on a larger patient sample would quite probably confirm a reduction of >20% in the per-patient costs observed over 180 days. In fact, the savings ...

4. nice.org.uk nice.org.uk/guidance/mib281/resources/freeo2-automatic-oxygen-titration-for-chronic-obstructive-pulmonary-disease-and-respiratory-distress-syndrome-pdf-2285965869772741

FreeO2 automatic oxygen titration for chronic obstructive ... The device is intended to be used in a hospital setting for treating chronic obstructive pulmonary disease (COPD) or acute respiratory distress ...

5. researchgate.net researchgate.net/publication/322683055_Cost-effectiveness_of_FreeO2_in_patients_with_chronic_obstructive_pulmonary_disease_hospitalised_for_acute_exacerbations_analysis_of_a_pilot_study_in_Quebec

Cost-effectiveness of FreeO2 in patients with chronic ... Results FreeO2 generated savings of 20.7% of the per patient costs at 180 days (ie, − C 2959.71 ) . T h i s d e c r e a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5003517/

Automated oxygen titration and weaning with FreeO2 in ... The aim of this study was to evaluate the feasibility of using FreeO2 in patients hospitalized in the respiratory ward for an acute exacerbation ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04189991

Oxygen Titration Protocol for Exertion of COPD Patients by ... Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial.