Automated vs Fixed Oxygen Therapy for Chronic Respiratory Disease

Overseen By Special Procedures Technologist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Park Healthcare Centre

Must be taking: Supplemental oxygen

Disqualifiers: Compromised oximetry, Non-English speakers

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of delivering oxygen therapy to individuals with chronic respiratory disease. One method uses a fixed oxygen flow, while the other automatically adjusts the oxygen level based on the patient's needs, using a sensor that measures blood oxygen levels. The goal is to determine if the automatic method (AutoO2) maintains oxygen levels in the desired range more effectively than the fixed method (FixedO2). Individuals with stable chronic respiratory disease who currently use supplemental oxygen might be suitable candidates for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance oxygen therapy for many.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on oxygen therapy, so it's best to ask the trial coordinators for guidance.

What prior data suggests that this automated oxygen therapy is safe for chronic respiratory disease patients?

Research has shown that automated oxygen control systems, like AutoO2, are effective and generally safe for individuals with long-term breathing problems. In earlier studies, systems such as AutoO2 and O2matic successfully maintained steady oxygen levels in patients with conditions like COPD, a type of chronic lung disease. These systems outperformed manual adjustments, and patients reported feeling less breathless during activities like walking.

These studies found no major safety issues, indicating that patients handle these automated systems well. Automated oxygen systems adjust oxygen levels based on real-time needs, maintaining stability without manual intervention. Overall, evidence indicates that automated oxygen delivery is a promising and safe method for managing oxygen therapy in individuals with chronic breathing issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of automated oxygen therapy because it offers a personalized approach to managing chronic respiratory disease. Unlike traditional fixed-flow oxygen delivery, which provides a constant oxygen flow regardless of a patient's changing needs, AutoO2 dynamically adjusts the oxygen level based on real-time pulse oximetry data. This closed-loop system aims to maintain optimal oxygen saturation, potentially improving patient outcomes by tailoring treatment to individual requirements.

What evidence suggests that this trial's treatments could be effective for chronic respiratory disease?

This trial will compare two approaches to oxygen therapy for chronic respiratory disease: AutoO2 and FixedO2. Research has shown that automated oxygen control systems, like AutoO2, can outperform fixed oxygen amounts. In one study, people with COPD (chronic obstructive pulmonary disease) who used automated oxygen felt less short of breath when walking. Another study found that these systems maintained blood oxygen levels more effectively than manual methods. Additionally, automated systems helped people exercise longer and feel less breathless during exercise. Overall, these promising results suggest that AutoO2 might manage oxygen more effectively for people with chronic breathing problems compared to fixed oxygen methods. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people with stable chronic respiratory diseases who are already on prescribed oxygen therapy. Participants must be able to communicate in English and should not have any issues that could affect the accuracy of oximetry readings.

Inclusion Criteria

My lung condition is stable and not getting worse.

I am currently prescribed supplemental oxygen.

Exclusion Criteria

Characteristics that compromise the validity of oximetry

I cannot communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants alternate weekly between fixed dose oxygen and automated oxygen titration over 4 weeks

4 weeks

Weekly monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AutoO2
• FixedO2

Trial Overview The study compares two methods of oxygen delivery: AutoO2, which adjusts oxygen flow automatically based on real-time needs using pulse oximetry, and FixedO2, a standard method with preset oxygen levels for different activities.

How Is the Trial Designed?

Group I: AutoO2 Experimental Treatment 1 Intervention

Automated Titration of Oxygen (Auto-O2) using a closed-loop system in which the oxygen flow to the participant is continuously adjusted on the basis of pulse oximetry signals to maintain a target range of oxygen saturation to meet the patient's immediate needs.

Group II: FixedO2 Active Control 1 Intervention

Fixed flow oxygen delivery administered using manual flow meters according to standard clinical procedures.

Who Is Running the Clinical Trial?

West Park Healthcare Centre

Lead Sponsor

Trials

36

Recruited

2,400+

Published Research Related to This Trial

In a study of 22 patients with decompensated COPD, controlled oxygen therapy at lower fractions (FIO2 0.24 and 0.28) significantly improved blood oxygen levels without greatly increasing carbon dioxide levels, but did not enhance oxygen delivery to tissues.

Higher oxygen fractions (FIO2 0.35 and 0.40) further improved oxygenation and tissue delivery but caused a significant increase in carbon dioxide levels, indicating that while oxygen therapy can enhance blood oxygenation, it may not effectively dilate pulmonary blood vessels in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute hemodynamic effects of controlled oxygen therapy in decompensated chronic obstructive pulmonary disease. Lejeune, P., Mols, P., Naeije, R., et al.[2019]

In a study involving 20 medical inpatients, automatic oxygen titration using a novel nasal high-flow device maintained oxygen saturation (SpO2) within the target range 96.2% of the time, compared to only 71% with manual titration, showing a significant improvement (p<0.001).

The automatic system also reduced the time spent with SpO2 levels outside the target range, indicating it is a more effective and safer method for managing oxygen therapy in acutely unwell patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic versus manual oxygen titration using a novel nasal high-flow device in medical inpatients with an acute illness: a randomised controlled trial. Harper, J., Kearns, N., Bird, G., et al.[2021]

In a study involving 33 COPD patients, automated oxygen titration significantly reduced dyspnea during walking, with patients reporting a median score of 4 compared to 8 with fixed-dose oxygen, indicating a substantial improvement in comfort (p < 0.001).

Patients using automated oxygen titration were able to walk for nearly 99% longer (10.9 minutes) compared to those on fixed doses (5.5 minutes), demonstrating that personalized oxygen delivery can enhance endurance and reduce hypoxemia during physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial. Kofod, LM., Westerdahl, E., Kristensen, MT., et al.[2021]

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]

In a study involving 42 adults with chronic respiratory disease, a novel nasal high-flow device with closed-loop oxygen control effectively maintained oxygen saturation levels within the target range of 92-96% during exercise and recovery periods.

The closed-loop system significantly improved the time spent in the target oxygen saturation range compared to room air and performed similarly to a fixed concentration of 28% oxygen, demonstrating its potential for better oxygen management in patients with hypoxemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-Loop Oxygen Control Using a Novel Nasal High-Flow Device: A Randomized Crossover Trial. Harper, JC., Kearns, NA., Maijers, I., et al.[2023]

The AccuO2 device effectively maintained blood oxygen levels (SpO2) at or above 90% in patients with COPD, showing less variability in oxygen levels compared to both continuous-flow oxygen and the standard CR-50 device.

The AccuO2 demonstrated a significantly higher conservation ratio, meaning it allowed for longer use of oxygen supplies compared to the CR-50, making it a more efficient option for home oxygen therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AccuO2 oximetry-driven oxygen-conserving device versus fixed-dose oxygen devices in stable COPD patients. Rice, KL., Schmidt, MF., Buan, JS., et al.[2022]

The O2matic® closed-loop system significantly improved the control of oxygen saturation (SpO2) in patients with COPD exacerbations, maintaining target SpO2 levels 85.1% of the time compared to only 46.6% with manual control.

Patients using O2matic experienced much less time with dangerously low SpO2 levels (<85%), with only 1.3% of the time below this threshold compared to 17.9% with manual control, indicating a safer and more effective method for oxygen delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated oxygen control with O2matic&#174; during admission with exacerbation of COPD. Hansen, EF., Hove, JD., Bech, CS., et al.[2022]

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]

Automated control of inspired oxygen (A-FiO2) has been successfully implemented in 38 centers across Poland, with 92 systems in use, showing perceived benefits in maintaining target oxygen saturation (SpO2) levels and reducing nurse workload.

While A-FiO2 is generally viewed positively, with few reported issues, there are concerns about over-reliance on automation and some instances of limited effectiveness in a small number of cases (14 out of 593).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine use of automated FiO2 control in Poland: prospective registry and survey. Wilinska, M., Bachman, TE., Piwowarczyk, P., et al.[2023]

Autonomous closed-loop controlled oxygen devices are more effective than traditional manual oxygen therapy, as they maintain higher oxygen saturation levels and reduce the time patients spend below target saturation, while also conserving oxygen resources.

Despite their advantages, these devices are not widely used in clinical settings due to issues like the reliability of sensors, the need for robust control algorithms, and usability challenges that must be resolved before they can be implemented more broadly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological closed-loop control in intelligent oxygen therapy: A review. Sanchez-Morillo, D., Olaby, O., Fernandez-Granero, MA., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06153485

Automated Titration for Home Oxygen Therapy The purpose of this study is to examine if automated oxygen control based on pulse oximetry provided to participants is superior to prescribed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6300382/

Automated oxygen control with O2matic® during admission ... O2matic was able to effectively control SpO 2 for patients admitted with an exacerbation of COPD. O2matic was significantly better than manual control.

3. withpower.com withpower.com/trial/phase-respiratory-tract-diseases-10-2023-ca51d

Automated vs Fixed Oxygen Therapy for Chronic ... In a study involving 33 COPD patients, automated oxygen titration significantly reduced dyspnea during walking, with patients reporting a median score of 4 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11951597/

Automatically titrating oxygen system versus constant flow ... ATOS may have more advantages in improving exercise tolerance, sustaining targeted SpO 2 , and ameliorating dyspnea during exercise in COPD patients.

5. publications.ersnet.org publications.ersnet.org/content/erj/62/suppl67/pa1040

Automated oxygen titration at home for patients with COPD Results: Two patients tested the setup for each 4 days. Pulse oximeter signal was achieved for 78.3 to 78.9 % of the time, with 272,399 paired observations of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30587955/

Automated oxygen control with O2matic® during admission ... O2matic was able to effectively control SpO 2 for patients admitted with an exacerbation of COPD. O2matic was significantly better than manual control.

7. medrxiv.org medrxiv.org/content/10.1101/2025.01.23.25320958v1.full-text

Automated Oxygen Delivery in Home Setting for Patients ... This randomized crossover trial evaluated the feasibility and preliminary effects of continuous automated oxygen titration in the homes of patients on LTOT.