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

Trial Summary

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 data supports the effectiveness of the treatment AutoO2 for chronic respiratory disease?

Research shows that automated oxygen systems, like AutoO2, can effectively adjust oxygen levels for patients with chronic respiratory diseases such as COPD, helping to maintain stable oxygen saturation and potentially reducing medical errors and improving patient outcomes. ^{1 2 3 4 5}

Is automated oxygen therapy safe for humans?

Automated oxygen therapy systems, like AutoO2, have been studied in patients with chronic respiratory diseases such as COPD. These systems aim to maintain stable oxygen levels and reduce medical errors, with preliminary data suggesting they are generally safe, though more research is needed to confirm their safety across different conditions. ^{4 5 6 7 8}

How is the AutoO2 treatment different from other treatments for chronic respiratory disease?

The AutoO2 treatment is unique because it uses an automated system to adjust oxygen flow based on the patient's needs, unlike traditional fixed-dose oxygen therapy that provides a constant flow regardless of activity level. This personalized approach helps maintain optimal oxygen levels, especially during activities like walking, improving endurance and reducing breathlessness. ^{1 5 7 9 10}

What is the purpose of this trial?

Patients with chronic respiratory disease may be prescribed oxygen therapy. Currently, the dose of oxygen flow is fixed (FixedO2) depending on activity level i.e. rest, physical activity and sleep. Automated Titration of Oxygen (AutoO2) is a closed-loop system in which the oxygen flow to the patient is continuously machine adjusted to meet the patient's immediate needs on the basis of signals from pulse oximetry (SpO2). The purpose of this study is to examine if automated oxygen control based on pulse oximetry provided to participants is superior to prescribed fixed oxygen flow in keeping SpO2 within the intended target interval of 92 to 96% arterial oxygen saturation.

Eligibility Criteria

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

I cannot communicate in English.

Characteristics that compromise the validity of oximetry

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Physiological closed-loop control in intelligent oxygen therapy: A review. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Routine use of automated FiO2 control in Poland: prospective registry and survey. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Automated oxygen control with O2matic&#174; during admission with exacerbation of COPD. [2022]

4. Egypt pubmed.ncbi.nlm.nih.gov

Optimal oxygen titration in patients with chronic obstructive pulmonary disease: a role for automated oxygen delivery? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Acute hemodynamic effects of controlled oxygen therapy in decompensated chronic obstructive pulmonary disease. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Closed-Loop Oxygen Control Using a Novel Nasal High-Flow Device: A Randomized Crossover Trial. [2023]

8. England 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

AccuO2 oximetry-driven oxygen-conserving device versus fixed-dose oxygen devices in stable COPD patients. [2022]

10. Switzerland 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. [2021]