Using an automated system to manage oxygen levels in critically ill patients
Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention (SAVE-O2 AI)
This study tests if an automated system for managing oxygen levels can help critically ill patients maintain the right amount of oxygen better than the usual manual methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 4 sites (Aurora, Colorado and 3 other locations) |
| Trial ID | NCT06374225 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial evaluates the effectiveness of the O2matic PRO100, an autonomous oxygen titration system, in maintaining optimal oxygen levels (normoxemia) in patients with acute injuries or illnesses. The study compares this automated approach to standard manual titration methods over the first 72 hours of hospitalization. By focusing on preventing both hypoxemia and hyperoxemia, the trial aims to reduce unnecessary oxygen use and improve patient outcomes in both military and civilian healthcare settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are hospitalized for major trauma, burns, acute care surgery, or acute respiratory illnesses and require supplemental oxygen.
Not a fit: Patients who are expected to be discharged within 24 hours or those with imminent plans to discontinue supplemental oxygen will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient safety by optimizing oxygen delivery and minimizing the risks associated with both low and high oxygen levels.
How similar studies have performed: Previous studies, such as the SAVE-O2 trials, have shown promise in using targeted oxygen management strategies, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Hospitalized or will be hospitalized from Emergency Department for major trauma, burn, acute care surgery, or acute respiratory illness * Able to be randomized within 36 hours of hospital arrival * Receiving supplemental oxygen 1-10 liters per minute for documented or presumed hypoxemia (must be higher than baseline for those on chronic oxygen therapy) * Signed and dated informed consent from patient or legally authorized representative (LAR) Exclusion Criteria: * Anticipated hospital discharge within 24 hours * Imminent plans to discontinue supplemental oxygen * Imminent plans to administer high flow nasal oxygen, non-invasive ventilation, or invasive mechanical ventilation * Clinical team unwilling or unable to follow the prescribed oxygen titration method in either randomized group * Known prisoner * Known pregnancy * Known contraindicated conditions for use of the PRO100 device: carbon monoxide poisoning, incapable of handling airway secretions, increased methemoglobin, cyanide poisoning, cluster headaches, undrained pneumothorax, sickle cell crisis, paraquat poisoning or a history of bleomycin poisoning, patients for whom the SpO2 signal is not stable
Where this trial is running
Aurora, Colorado and 3 other locations
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
- Oregon Health and Sciences University — Portland, Oregon, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Erin Anderson
- Email: erin.l.anderson@cuanschutz.edu
- Phone: 720-999-8760
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.