Automated Oxygen Titration for Critical Illness

(SAVE-O2 AI Trial)

Recruiting at 3 trial locations

Overseen By Adit Ginde, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Prisoner, Pneumothorax, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%).

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 data supports the effectiveness of the Automated Titration (O2matic) treatment for critical illness?

Research shows that automated oxygen systems like O2matic can help keep oxygen levels within the desired range better than manual methods, which is important for patients with conditions affecting their heart and lungs. This suggests that the treatment could be effective in managing oxygen levels in critically ill patients. ^{1 2 3 4 5}

Is automated oxygen titration safe for humans?

Research on automated oxygen titration systems, like O2matic, suggests they are generally safe for use in humans. These systems have been tested in various conditions, including acute cardiovascular disease and hypoxemia (low blood oxygen levels), and aim to maintain stable oxygen levels without significant safety concerns. ^{1 2 5 6 7}

How is the Automated Titration (O2matic) treatment different from other treatments for critical illness?

The Automated Titration (O2matic) treatment is unique because it uses a closed-loop system to automatically adjust oxygen levels, maintaining stable oxygen saturation without manual intervention. This contrasts with traditional methods where healthcare providers manually adjust oxygen flow, which can lead to fluctuations outside the desired range. ^{1 2 6 7 8}

Eligibility Criteria

This trial is for patients with acute injuries or illnesses who need oxygen therapy. They must be in a hospital that can use the O2matic PRO100 system. There's no specific list of conditions, but they should require close monitoring of blood oxygen levels.

Inclusion Criteria

Signed and dated informed consent from patient or legally authorized representative (LAR)

I am hospitalized or will be for a major injury, burn, surgery, or severe respiratory issue.

I need extra oxygen (1-10 liters per minute) due to low oxygen levels.

Exclusion Criteria

I plan to stop using extra oxygen soon.

Known pregnancy

Anticipated hospital discharge within 24 hours

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either autonomous or manual oxygen titration for the first 72 hours after randomization

72 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including time to room air and overall oxygen utilization

up to 28 days

Treatment Details

Interventions

• Automated Titration (O2matic)

Trial Overview The study tests if an automated machine called O2matic PRO100 can better control oxygen levels in the blood compared to standard manual adjustments by healthcare providers. Patients are randomly chosen to receive either the new device or usual care for 72 hours.

Participant Groups

Group I: Intervention (Automated Titration) Experimental Treatment 1 Intervention

Patients randomized to the intervention arm will receive supplemental oxygen via nasal cannula (recommended up to 6 lpm) or face mask (recommended up to 15 lpm) and will have supplemental oxygen titrated using an autonomous oxygen titration system for the first 72 hours after randomization, or hospital discharge (whichever sooner).

Group II: Usual Care (Manual Titration) Active Control 1 Intervention

Patients randomized to the usual care arm will receive usual care, manual oxygen titration, removal of supplemental oxygen, and escalation per hospital protocol, based on the site's usual SpO2 assessments. The SpO2 monitor for the O2matic PRO100 will also be connected to the patient in observation mode for data collection purposes only (not used for titration decisions).

Automated Titration (O2matic) is already approved in European Union for the following indications:

Approved in European Union as O2matic PRO 100 for:

• Respiratory diseases
• Chronic obstructive pulmonary disease (COPD)
• Acute injury or illness requiring oxygen therapy

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

IDTS Medical, Inc.

Collaborator

Trials

1

Recruited

300+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

O2matic ApS

Collaborator

Trials

1

Recruited

300+

Findings from Research

This study will evaluate the effectiveness of an automated oxygen administration system called O2matic in maintaining optimal oxygen levels (92-96% saturation) in patients with cardiovascular or pulmonary issues, compared to standard care.

The trial involves a randomized design with patients receiving either conventional oxygen treatment or O2matic for 24 hours, aiming to determine if the automated system can better prevent both hypoxaemia and hyperoxia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated versus manual oxygen administration for patients admitted with acute cardiovascular disease - a study protocol of a randomised controlled trial. Taraldsen, IA., Grand, J., Lukoschewitz, JD., 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]

In a study involving 30 pediatric patients, the use of a closed-loop control system for adjusting oxygen levels (FiO2) significantly increased the time spent in optimal oxygen saturation (SpO2) zones compared to manual adjustments, with results showing 96.1% vs. 78.4% (P < 0.001).

The closed-loop system not only improved oxygen saturation but also required a higher number of adjustments (52 changes per patient) compared to manual titration (1 change per patient), indicating a more responsive and effective management of oxygen levels in critically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated closed-loop FiO2 titration increases the percentage of time spent in optimal zones of oxygen saturation in pediatric patients-A randomized crossover clinical trial. Soydan, E., Ceylan, G., Topal, S., et al.[2022]

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]

This systematic review and meta-analysis aims to evaluate the effectiveness and safety of closed-loop oxygen control systems for managing hypoxaemia in hospitalized patients, focusing on primary outcomes like time spent within target oxygen saturation levels.

The study will analyze various secondary outcomes, including oxygen weaning time, length of hospital stay, costs, adverse events, and healthcare professionals' workload, to determine the overall impact of this technology on patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed-loop oxygen control for patients with hypoxaemia during hospitalisation: a living systematic review and meta-analysis protocol. Mol, CG., Vieira, AGDS., Garcia, BMSP., et al.[2022]

The FreeO(2) system, which automatically adjusts oxygen flow, maintained target oxygen saturation (S(pO(2))) levels between 92% and 96% significantly better than both constant oxygen flow and air, achieving this target 66.5% of the time compared to 26.0% and 36.8%, respectively.

Using the FreeO(2) system resulted in a dramatic reduction in severe hypoxemia (S(pO(2) < 88%)) to only 0.4% of the time, while also minimizing hyperoxia, demonstrating its efficacy in managing oxygen delivery with less overall oxygen consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated oxygen flow titration to maintain constant oxygenation. Lellouche, F., L'her, E.[2016]

In a study of 36 hospitalized subjects, reducing the target oxygen saturation from 98% to 90% led to more than a 6-fold decrease in the required oxygen flow, highlighting the potential for significant oxygen savings with optimized targets.

Automated oxygen titration was effective in correcting hypoxemia in both healthy subjects and those with COPD, demonstrating that individualized oxygen delivery can be achieved while minimizing oxygen utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen Conservation Methods With Automated Titration. Bourassa, S., Bouchard, PA., Dauphin, M., et al.[2021]

A new automated measurement system has been developed to accurately measure oxygen consumption and carbon dioxide production, which can be connected to any commercial ventilator.

The system uses affordable components and a microprocessor for calculations and display, and is currently being tested in clinical settings to evaluate its effectiveness and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of an automated system for assessing metabolic function in mechanically ventilated patients. Bairiot, M., Reynaert, M., Roeseler, J., et al.[2013]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Automated versus manual oxygen administration for patients admitted with acute cardiovascular disease - a study protocol of a randomised controlled trial. [2023]

2. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Automated closed-loop FiO2 titration increases the percentage of time spent in optimal zones of oxygen saturation in pediatric patients-A randomized crossover clinical trial. [2022]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Closed-loop oxygen control for patients with hypoxaemia during hospitalisation: a living systematic review and meta-analysis protocol. [2022]

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

Automated oxygen flow titration to maintain constant oxygenation. [2016]

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

Oxygen Conservation Methods With Automated Titration. [2021]

8. Belgium pubmed.ncbi.nlm.nih.gov

Design of an automated system for assessing metabolic function in mechanically ventilated patients. [2013]