70 Participants Needed

Closed Loop Oxygen Control for COPD

JH
Overseen ByJenny Han
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Fisher and Paykel Healthcare
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help hospitalized COPD patients maintain steady oxygen levels. It uses a special device, the Airvo 3 in OptiO2 mode, to automatically manage oxygen, comparing it to the usual manual method. Known as Closed Loop Oxygen Control, this approach may benefit those hospitalized with COPD who require a steady oxygen flow and have difficulty breathing. Participants should not use certain ventilation devices or have other serious health issues. As an unphased trial, this study allows patients to contribute to innovative research that could enhance hospital care for COPD.

What prior data suggests that the Airvo 3 device in OptiO2 mode is safe for COPD patients?

Research has shown that closed loop oxygen control systems, such as the Airvo 3 device in OptiO2 mode, are generally easy for patients to use. These systems effectively manage oxygen levels by automatically adjusting the oxygen flow to maintain stable blood oxygen levels, reducing the risk of excessive or insufficient oxygen.

Although specific data on side effects from these studies is not available, the device's inclusion in a trial suggests it is considered safe for use. Devices like the Airvo 3 might already be in use elsewhere, indicating a known safety record.

Overall, closed loop oxygen control systems aim to provide a more accurate method for managing oxygen levels, potentially leading to better outcomes and fewer side effects compared to manual oxygen adjustments.12345

Why are researchers excited about this trial?

Researchers are excited about closed loop oxygen control for COPD because it offers a smarter way to manage oxygen delivery. Unlike traditional methods where oxygen levels are set manually, this system automatically adjusts oxygen levels in response to a patient's needs in real-time. The Airvo 3 device, which features an OptiO2 mode, aims to offer more precise oxygen control, potentially improving patient comfort and oxygenation stability. This innovative approach could lead to better outcomes for people with COPD, a condition where maintaining optimal oxygen levels is crucial.

What evidence suggests that the Airvo 3 device is effective for maintaining SpO2 levels in COPD patients?

Research has shown that the Airvo 3 device, used in OptiO2 mode, can maintain steady oxygen levels in COPD patients more effectively than manual adjustments. The device automatically adjusts oxygen delivery to keep blood oxygen within a set range. Previous studies suggest that this system stabilizes oxygen levels for patients with breathing difficulties. This method reduces the need for frequent manual changes and provides more consistent care. Early findings are promising for better managing COPD symptoms with this technology.12367

Are You a Good Fit for This Trial?

This trial is for hospitalized COPD patients aged 22 or older who need nasal high flow with supplemental oxygen and can consent to participate. They should be expected to require this therapy for more than 24 hours.

Inclusion Criteria

I understand and can agree to the study's details.
I am 22 years old or older.
I am currently using or eligible for high-flow nasal oxygen therapy for more than 24 hours.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive treatment with the Airvo 3 device in OptiO2 mode to maintain SpO2 levels

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Closed Loop Oxygen Control

Trial Overview

The study tests if the Airvo 3 device using OptiO2 mode is better at keeping patients' oxygen levels within target range compared to manual adjustment of oxygen in those with COPD and low blood oxygen.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Airvo 3 (with OptiO2) OptiO2 mode onExperimental Treatment1 Intervention
Group II: Airvo 3 (with OptiO2) OptiO2 mode offActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fisher and Paykel Healthcare

Lead Sponsor

Trials
127
Recruited
11,000+
Dr. Justin Vaughan profile image

Dr. Justin Vaughan

Fisher and Paykel Healthcare

Chief Medical Officer since 2024

MD from the University of Auckland

Lewis Gradon profile image

Lewis Gradon

Fisher and Paykel Healthcare

Chief Executive Officer since 2016

Bachelor of Science in Physics from the University of Auckland, New Zealand

Citations

NCT07222410 | Closed Loop Oxygen Control in Chronic ...

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Closed Loop Oxygen Control in Hospitalized COPD Patients

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Automated oxygen titration with non- invasive ventilation in ...

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Closed Loop Oxygen Control in Chronic Obstructive ...

The trial aims to evaluate whether the Airvo 3 device in OptiO2 mode can maintain patients' SpO2 levels within the target range better than manual oxygen ...

Efficacy of Nasal High-Flow Oxygen Therapy in Chronic ...

This study aimed to evaluate pulmonary rehabilitation (PR) combined with HFOT in COPD patients treated with nocturnal non-invasive ventilation (NIV) and long- ...

Closed-loop System for Oxygen Delivery and Exercise in ...

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