IMPORTANCE: For acutely ill adults who are hospitalized with hypoxemia, supplemental oxygen is titrated to maintain normoxemia. In current practice, clinicians intermittently titrate oxygen, potentially exposing patients to hypoxemia and hyperoxemia between assessments. Autonomous oxygen titration may address these challenges by independently titrating supplemental oxygen flow to maintain peripheral oxygen saturation (Spo2) within a predefined range.
OBJECTIVE: To determine whether autonomous oxygen titration increases the proportion of time spent in a targeted normoxemia range compared with usual care in acutely ill adults.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, unblinded, parallel-group, randomized clinical trial was conducted at 4 US hospitals from May 6, 2024, to November 17, 2025, among adults hospitalized for acute respiratory illness, trauma, burn, or acute care surgery who were receiving supplemental oxygen.
INTERVENTION: Patients were randomly assigned to receive oxygen titration via either autonomous oxygen titration or usual care (manual oxygen titration by clinicians) during the first 72 hours after randomization.
MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of time spent within the targeted normoxemia range (Spo2 90%-96%). The key secondary outcome was the proportion of time spent in hypoxemia (Spo2 <88%).
RESULTS: Among 300 patients randomized and included in the trial population (median [IQR] age, 66 (55-75) years; 162 [54%] female), 152 were assigned to autonomous oxygen titration and 148 to usual care. Participants represented a range of skin pigmentation categories defined by the Monk Skin Tone Scale, including 67 (22%) categorized as light, 168 (56%) as medium, and 65 (22%) as dark. The mean (SE) proportion of time spent in normoxemia was greater in the autonomous oxygen titration group than in the usual care group (85% [1%] vs 63% [2%]; adjusted risk difference [RD], 21 percentage points [pp]; 95% CI, 18-25 pp; P < .001). The mean (SE) proportion of time spent in hypoxemia was lower in the autonomous oxygen titration group than in the usual care group (2.0% [0.2%] vs 3.6% [0.4%]; adjusted RD, -1.3 pp; 95% CI, -2.0 to -0.5 pp; P = .002). The mean (SE) proportion of time spent in hyperoxemia (Spo2 >96%) was 9.2% (1.0%) in the autonomous oxygen titration group and 29.1% (1.7%) in the usual care group. The mean (SE) proportion of time spent in borderline hypoxemia (Spo2 88%-89%) was 3.4% (0.3%) in the autonomous oxygen titration group and 4.0% (0.4%) in the usual care group. Results were consistent across prespecified subgroups.
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial among adults hospitalized with an acute illness or injury and receiving supplemental oxygen, autonomous oxygen titration substantially increased the proportion of time spent in normoxemia and decreased time spent in hypoxemia compared with usual care.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06374225.
| Discipline Area | Score |
|---|---|
| Hospital Doctor/Hospitalists |  |
| Internal Medicine | |
| Respirology/Pulmonology | |
| Intensivist/Critical Care |  |
Brilliant approach to a very common and important clinical task. Oxygen saturation is of course still only a physiologic surrogate marker for more important clinical outcomes such as mortality, etc. Nonetheless, we rely on it a lot and consider normoxemia to be an important part of care. Beyond clinical benefits, there is potential to improve workflow by reducing work burden on nurses, respiratory therapists, and physicians who commonly perform this task (although this aspect of the intervention was not studied here). Still some unanswered questions and the study was not blinded, but it represents a novel approach to a common clinical issue.
Not practice-changing given surrogate outcome and relatively small numbers, but interesting nonetheless.
Interesting observation for a pilot trial. Unclear benefits in heart endpoints at this point.
The intervention group mainly avoided hyperoxemia, while hypoxemia was largely avoided in both groups. Further studies are needed to look at outcomes.
In hospital inpatients requiring supplemental oxygen, an autonomous oxygen titration system significantly improved time spent with oxygen saturations in the target range and reduced time spent in hyperoxia and hypoxemia, compared to usual care. Results were similar among patients with darker skin tones and those with chronic lung diseases. Further validation is needed in hypercapnic patients, as the target range of 90-96% is broader than the usual range of 88-92% required. However, these are very promising results suggesting a role for an AI-based technology to improve patient care.