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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve oxygen management for critically ill patients on mechanical ventilators. It compares electronic alerts for adjusting oxygen levels with the usual care method, where respiratory therapists manually adjust oxygen every few hours. The goal is to determine if electronic alerts lead to better oxygen levels by prompting healthcare providers to make more effective adjustments. This trial is suitable for adults on mechanical ventilation but excludes those with specific conditions like pneumothorax (collapsed lung) or carbon monoxide poisoning. As an unphased trial, it provides a unique opportunity to contribute to advancements in critical care technology.

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 prior data suggests that this electronic oxygen titration system is safe for mechanically ventilated patients?

Research shows that using electronic alerts to adjust oxygen levels in patients on mechanical ventilation is generally safe. A small initial study found this method practical and well-received. The study aimed to maintain safe oxygen levels by using electronic health records to guide adjustments.

No major safety issues emerged with this method. The electronic alerts reminded healthcare workers to adjust the oxygen, typically done every four hours. This constant monitoring helped prevent the risks of administering too much or too little oxygen.

While the study didn't identify significant problems specifically linked to the electronic alert system, it's important to remember that this is a newer method of managing oxygen. As with any medical treatment, ongoing research continues to ensure its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to manage oxygen levels in patients on mechanical ventilation. Unlike the standard method, where oxygen is adjusted manually every few hours, this approach uses an electronic alert system to provide timely reminders for oxygen adjustments. This could lead to more precise control of oxygen levels, potentially reducing the risk of complications from too much oxygen, known as hyperoxia. By fine-tuning oxygen delivery with real-time alerts, this method aims to improve patient outcomes and make care more efficient.

What evidence suggests that the FiO2 electronic alert system is effective for oxygen titration in mechanically ventilated patients?

This trial will compare two methods of oxygen titration for mechanically ventilated patients. Research has shown that electronic alerts can help maintain optimal oxygen levels in ventilated patients. In this trial, one arm will use electronic alerts to guide oxygen adjustments. Studies have found that this approach successfully reduces the risk of excessive oxygen in the blood. Early findings suggest that electronic alerts improve the frequency and accuracy of oxygen level adjustments, enhancing patient safety. By combining two measures of oxygen levels, this system achieves optimal oxygen levels more effectively than traditional methods. Overall, automated systems for managing oxygen show promise in improving patient outcomes. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9187203/

Early Titration of Oxygen During Mechanical Ventilation ... In this pilot study, we examined the feasibility, safety, and efficacy of a clinical trial to prioritize Fio2 titration with electronic alerts ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05923853

Electronic Optimization of Inspired Oxygen During ... Per the ventilator management guidelines assessment for FiO2 titration is recommended at least once in 4 hours to maintain oxygenation with the optimal range.

3. perioperativemedicinejournal.biomedcentral.com perioperativemedicinejournal.biomedcentral.com/articles/10.1186/s13741-024-00456-x

Assessing the incidence of hyperoxia and the effectiveness of ... The combined use of SpO2 and ORi has been demonstrated to successfully guide FiO2 titration for optimal oxygenation and reduce hyperoxemia.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11114599/

Rationale and design of a randomized controlled clinical trial This study is designed to evaluate the efficacy of a high fidelity, bioinformatics-based, electronic medical record derived electronic alert system to improve ...

5. withpower.com withpower.com/trial/phase-hyperoxia-9-2023-fb266

Electronic Oxygen Adjustment for Hyperoxia What data supports the effectiveness of the treatment FiO2 titration using an electronic alert system? Research shows that using automated systems for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04481581

Study Details | NCT04481581 | Titration of Oxygen Levels ... The investigators propose an approach using a oxygen titration protocol consisting of electronic health records based alerts to guide oxygen adjustment.