Electronic Oxygen Adjustment for Hyperoxia

Overseen By Sarah Karow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

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

936 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on oxygen adjustment for patients on mechanical ventilation.

What data supports the effectiveness of the treatment FiO2 titration using an electronic alert system?

Research shows that using automated systems for oxygen titration helps keep patients' oxygen levels within the target range more effectively than manual methods. This approach reduces the time patients spend with too much or too little oxygen, which can improve overall treatment outcomes. ^{1 2 3 4 5}

Is electronic oxygen adjustment safe for humans?

Research shows that systems automating oxygen adjustments, like Auto-FiO2, are generally safe and effective. Studies also indicate that using electronic alerts and automated systems can help manage oxygen levels safely, reducing unnecessary alarms and improving patient safety. ^{3 4 6 7 8}

How does the Electronic Oxygen Adjustment for Hyperoxia treatment differ from other treatments?

The Electronic Oxygen Adjustment for Hyperoxia treatment is unique because it uses an electronic alert system to automatically adjust oxygen levels, ensuring patients stay within a safe oxygen range more effectively than manual adjustments. This automated approach improves adherence to oxygenation guidelines and reduces the risk of excessive oxygen exposure, which is a common issue with manual titration. ^{1 2 4 5 9}

What is the purpose of this trial?

OPTI-Oxygen is a single center, stepped wedged, cluster-randomized, un-blinded, pragmatic, comparing the use of a combined inspired oxygen (FiO2) and peripheral oxygen saturation (SpO2) titration strategy utilizing electronic health records (EHR) based electronic alerts (e-alerts) for respiratory therapists in mechanically ventilated critically ill adults. All eligible mechanically ventilated patients, FiO2 titration and SpO2 goal range will be based on the correlation between SpO2 and arterial oxygen saturation (SaO2). E-alerts will be sent in the intervention arm as reminders for FiO2 titration. In the control arm, patients will have oxygen titrated per current standard of care (SpO2=88-92%, titrate FiO2 at least every 4 hours).

Eligibility Criteria

This trial is for adults over 18 years old who are critically ill and require mechanical ventilation. It's not suitable for those who don't meet the age requirement or aren't on mechanical breathing support.

Inclusion Criteria

You are using a machine to help you breathe.

I am older than 18 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Implementation

Initial implementation period for transitioning clusters from control to intervention

2 weeks

Intervention

Clusters transition from control to intervention every 6 weeks with e-alerts for FiO2 titration

6 weeks per cluster

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• FiO2 titration using electronic alert system

Trial Overview The OPTI-Oxygen trial tests a new system that uses electronic alerts to help adjust oxygen levels in patients on ventilators. The goal is to see if this method, compared to standard care, better manages oxygen saturation in critically ill adults.

Participant Groups

Group I: Oxygen (FiO2) Titration per E-alerts Experimental Treatment 1 Intervention

All eligible mechanically ventilated patients, FiO2 titration and SpO2 goal range will be based on the correlation between SpO2 and arterial oxygen saturation (SaO2). E-alerts will be sent in the intervention arm as reminders for FiO2 titration.

Group II: Oxygen Titration per Standard of Care Active Control 1 Intervention

In the control arm, patients will have oxygen titrated per current standard of care (SpO2=88-92%, titrate FiO2 at least every 4 hours). Physician place oxygen titration orders in EMR and respiratory therapists conduct FiO2 titration without electronic alerts.

FiO2 titration using electronic alert system is already approved in United States for the following indications:

Approved in United States as FiO2 Titration Using Electronic Alert System for:

• Mechanical ventilation management in critically ill adults

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study of 187 patients requiring oxygen therapy, automated closed-loop titration significantly improved the time spent within target oxygen saturation levels (81% vs. 51% for manual titration), indicating better adherence to treatment guidelines.

Automated titration also reduced the prevalence of hypoxaemia and hyperoxia, allowed for earlier weaning of oxygen in 14.1% of patients compared to 4.3% in the manual group, and decreased the duration of oxygen therapy during hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic versus manual oxygen administration in the emergency department. L'Her, E., Dias, P., Gouillou, M., 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]

An automated FiO2 controller effectively maintained oxygen saturation (SpO2) within the target range of 92% to 96% in critically ill patients, achieving over 95% time in the target range during a 3-hour study with 20 patients.

The controller significantly reduced the duration of both hyperoxemia and hypoxemia compared to usual care, with a remarkable increase in reaching the SpO2 target range (90% with the controller vs. 24-32% with historical controls).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of an automated controller of inspired oxygen concentration during mechanical ventilation. Saihi, K., Richard, JC., Gonin, X., et al.[2021]

In a pilot study involving 135 adults on mechanical ventilation, the use of automated electronic alerts for early titration of oxygen (Fio2) significantly reduced exposure to hyperoxemia by a median of 7.5 hours compared to standard care.

The intervention also led to a reduction in the duration of mechanical ventilation and ICU length of stay, while only a small percentage of alerts (12%) were associated with minor hypoxemic events, indicating a safe and effective approach to oxygen management in the ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Titration of Oxygen During Mechanical Ventilation Reduces Hyperoxemia in a Pilot, Feasibility, Randomized Control Trial for Automated Titration of Oxygen Levels. Pannu, SR., Exline, M., Klamer, B., 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 21 neonates in a NICU, using a looser alarm strategy with Auto-FiO2 significantly reduced the frequency of SpO2 alarms from 5.2 to 1.6 per hour, which helps prevent alarm fatigue among caregivers.

The looser alarm strategy did not increase the time spent at dangerously low or high oxygen saturation levels, indicating that it is a safe approach to managing oxygen levels in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of two SpO2 alarm strategies during automated FiO2 control in the NICU: a randomized crossover study. Warakomska, M., Bachman, TE., Wilinska, M.[2020]

In a study of 50 patients with severe COPD, the automatically titrating oxygen system (ATOS) significantly improved walking endurance time compared to the titrated constant flow oxygen system (CFOS), with an increase of about 144.5 seconds (p<0.001).

ATOS also resulted in higher oxygen saturation (SpO2) levels and improved blood oxygen pressure (PO2) while reducing feelings of breathlessness (dyspnoea) at the end of exercise, indicating its efficacy in enhancing exercise capacity without negatively affecting carbon dioxide levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic oxygen titration versus constant oxygen flow rates during walking in COPD: a randomised controlled, double-blind, crossover trial. Schneeberger, T., Jarosch, I., Leitl, D., et al.[2023]

The use of Oxygen Alert Wristbands (OxyBands) significantly reduced inappropriate oxygen prescriptions in patients at risk of hypercapnic acidosis, indicating improved safety in oxygen therapy administration.

A majority of clinicians understood the risks associated with uncontrolled oxygen use, and 42 out of 44 patients found the OxyBands comfortable, suggesting they could be a more effective tool than traditional Oxygen Alert Cards for ensuring safe oxygen delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen alert wristbands (OxyBand) and controlled oxygen: a pilot study. Rickards, E., Wat, D., Kelly, CA., et al.[2020]

In a study of 151 ICU patients on mechanical ventilation, 46% were found to be in the hyperoxaemic range, indicating that many patients were receiving higher levels of oxygen than necessary, which can lead to worse outcomes.

Despite guidelines suggesting titration of oxygen based on arterial blood gas results, only 31% of patients had their FiO2 adjusted, highlighting a potential area for improvement in oxygen management practices in the ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A snapshot of the oxygenation of mechanically ventilated patients in one Australian intensive care unit. Dennis, D., Torre, L., Baker, S., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Automatic versus manual oxygen administration in the emergency department. [2022]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of an automated controller of inspired oxygen concentration during mechanical ventilation. [2021]

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

Early Titration of Oxygen During Mechanical Ventilation Reduces Hyperoxemia in a Pilot, Feasibility, Randomized Control Trial for Automated Titration of Oxygen Levels. [2023]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of two SpO2 alarm strategies during automated FiO2 control in the NICU: a randomized crossover study. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Automatic oxygen titration versus constant oxygen flow rates during walking in COPD: a randomised controlled, double-blind, crossover trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Oxygen alert wristbands (OxyBand) and controlled oxygen: a pilot study. [2020]

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

A snapshot of the oxygenation of mechanically ventilated patients in one Australian intensive care unit. [2019]