Randomized U.S. Trial Finds Autonomous Oxygen System Significantly Improves Precision of Hospital Oxygen Therapy

A randomized, multicenter U.S. clinical trial has demonstrated that an autonomous oxygen titration system significantly improves the precision of supplemental oxygen delivery in hospitalized patients, according to findings published today in JAMA Internal Medicine and presented simultaneously at the Military Health System Research Symposium.

The SAVE-O2 AI trial, led by investigators at the University of Colorado Anschutz School of Medicine (搜索)搜索该词条, enrolled 300 adults at four U.S. hospitals: UCHealth University of Colorado Hospital, Vanderbilt University Medical Center, Oregon Health & Science University, and Wake Forest University School of Medicine. Patients were randomly assigned to receive either standard clinician-managed oxygen therapy or autonomous oxygen titration using the O2matic PRO100 (搜索)搜索该药品, a device that continuously monitors blood oxygen saturation via pulse oximetry and adjusts oxygen flow in real time.

The primary finding: patients treated with the O2matic system spent 85% of their monitored time within the prescribed oxygen range, compared with 63% among patients receiving standard care—a 35% relative increase.

"Oxygen is one of the most widely used therapies in medicine, yet it is still managed largely through repeated manual adjustments by clinicians," said Adit Ginde, MD, MPH, senior associate dean for clinical research and professor of emergency medicine at the University of Colorado Anschutz School of Medicine (搜索)搜索该词条 and principal investigator of the study. "Our findings show that autonomous oxygen titration with the O2matic PRO100 (搜索)搜索该药品 helped patients remain in their target oxygen range more consistently while reducing exposure to both under- and over-oxygenation."

The Clinical Burden of Manual Oxygen Management

Oxygen is among the most frequently used treatments in hospital and emergency care. A 2025 Lancet Global Health Commission on medical oxygen security estimated that 374 million people worldwide need oxygen therapy each year, including 364 million patients with acute medical or surgical needs. Despite this scale, oxygen delivery remains largely dependent on intermittent manual management by nurses or respiratory therapists during periodic patient checks.

Maintaining patients within prescribed oxygen ranges is clinically important because both insufficient and excessive oxygen exposure have been associated with adverse outcomes, and a patient's oxygen needs can change rapidly between assessments. In current hospital practice, this approach requires repeated attention and can allow oxygen levels to drift outside the target range between assessments.

Key Efficacy Findings

The study included hospitalized adults with acute respiratory illness (搜索)搜索该疾病, traumatic injuries, burns, and patients recovering from surgery who had recently begun receiving supplemental oxygen. Participants were randomly assigned to standard oxygen management or autonomous titration using the O2matic PRO100 (搜索)搜索该药品 targeting a normoxemia range of SpO₂ 90–96%.

Compared with standard care, patients receiving autonomous oxygen titration demonstrated:

• 85% vs. 63% of monitored time within the target oxygen range
• 45% less time in hypoxemia (excessively low oxygen levels)
• 68% less time in hyperoxemia (excessively high oxygen levels)
• Approximately 23% less daily oxygen use, receiving a lower overall volume of supplemental oxygen
• Fewer manual adjustments required by clinical staff
• No increase in serious adverse events

"Oxygen levels can change quickly in hospitalized patients," said David Douin, MD, MSc, associate professor of anesthesiology at the University of Colorado Anschutz School of Medicine (搜索)搜索该词条 and first author of the study. "This system responds in real time, helping patients spend more time in their target oxygen range with less manual adjustment."

Implications for Civilian and Military Medicine

The findings reflect a broader effort through the CU Anschutz Combat Medicine Research Center to improve oxygen therapy across the continuum of care. Prior research led by Drs. Douin and Ginde has shown that targeting moderate oxygen levels is safe in critically ill and injured patients and may reduce unnecessary exposure to higher oxygen levels.

"When you are caring for a wounded service member hours from a hospital, oxygen runs short and so does the medic's attention," said Vik Bebarta, MD, chair of emergency medicine, founding director of the CU Anschutz Combat Medicine Research Center, and a U.S. Air Force Reserve colonel. "A device that adjusts oxygen on its own takes one urgent task off their hands so they can focus on everything else the patient needs."

Researchers noted that the system may reduce workload for nurses and respiratory therapists, allowing clinicians to focus on other aspects of patient care. Changes in workload will be the subject of future investigations.

Next Phase: The AURORA Program

The SAVE-O2 AI study is part of a broader CU Anschutz research program to modernize oxygen delivery. The next phase, the two-year AURORA program, will continue the collaboration with O2matic and evaluate its technology in ambulances, medical helicopters, and military settings, where clinicians must manage critically ill or injured patients with limited time, attention, and oxygen supplies.

"We look forward to continuing our collaboration through the AURORA project as we evaluate autonomous oxygen therapy in patient transport," said Farzad Saber, Chief Business Development Officer at O2matic. "This study's findings show how autonomous oxygen titration can improve precision in oxygen delivery and reduce the burden of routine manual adjustments, especially in emergency and transport settings where staff time and oxygen supplies are limited."

Regulatory Status and Funding

The O2matic PRO100 (搜索)搜索该药品 used in the trial is a CE-marked Class IIb medical device under the European Union Medical Device Regulation. In the United States, the PRO100 remains investigational and has not been cleared or approved by the U.S. Food and Drug Administration for commercial use. The trial was conducted under an FDA Investigational Device Exemption sponsored by IDTS Medical, Inc.

The study was sponsored by the U.S. Department of War's Defense Health Agency Research and Engineering Directorate, Combat Casualty Care Portfolio, through the Medical Technology Enterprise Consortium. Additional support was provided by the National Center for Advancing Translational Sciences. O2matic had no role in study design, data collection, analysis, or publication decisions.

O2matic is currently engaging with prospective strategic and financial investors regarding an additional closing of its Series A financing, which would support U.S. regulatory activities, continued clinical development, and preparations for commercial expansion.