An interventional study of Automated Titration (O2matic) in Critical Illness, Wounds and Injury and Disease Attributes, sponsored by University of Colorado, Denver. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
Douin DJ, Rice JD, Xiao M, Beaty LE, Guo CJ, Withers C, Sullivan A, Anderson EL, Cheng AC, Banasiewicz MK, Semler MW, Lloyd BD, Maiga AW, Gibbs KW, Stettler GR…PubMed 42546017 ↗
This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%).
Ensuring adequate oxygenation is a primary goal in surgical and medical patients to treat and prevent morbidity associated with hypoxemia. However, excessive oxygen administration resulting in hyperoxemia is common, leading to unnecessary utilization of supplemental oxygen, which is a particularly limited resource in austere settings. Building on the previous Strategy to Avoid Excessive Oxygen (SAVE-O2) clinical trials1 (Trauma: NCT045349559; Burn: NCT04534972), the investigators seek to determine effective strategies to implement a targeted normoxemia approach to avoid both hyperoxemia and hypoxemia and reduce supplemental oxygen use, using the PRO100 closed loop/autonomous oxygen system. This research is critical for both military and civilian care settings in determining the effectiveness of an autonomous oxygen system to use to 1) reduce harm associated with both hypoxemia and hyperoxemia and 2) reduce excess use of oxygen.
Objectives: the investigators propose the following two objectives:
Determine the effectiveness of an autonomous oxygen titration system to improve normoxemia and reduce hypoxemia and hyperoxemia in acutely injured and ill patients receiving supplemental oxygen. The investigators will compare patient-hours spent in normoxemia (SpO2 90-96%), hypoxemia (SpO2 \<88%), and hyperoxemia (SpO2 >96%) among patients randomized to autonomous vs manual oxygen titration.
Determine the impact of an autonomous oxygen titration system on overall utilization of supplemental oxygen. The investigators will compare the total volume of supplemental oxygen administered to patients randomized to autonomous vs manual oxygen titration during the 72-hour intervention period.
Hypothesis: The investigators hypothesize that the use of an autonomous oxygen titration system will be more effective at maintaining normoxemia and reducing time spent in hypoxemia/hyperoxemia than standard manual titration in non-mechanically ventilated patients and will reduce the overall use of supplemental oxygen.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's enrollment of 300 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Compared within Wounds and Injuries, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to the usual care arm will receive usual care, manual oxygen titration, removal of supplemental oxygen, and escalation per hospital protocol, based on the site's usual SpO2 assessments. The SpO2 monitor for the O2matic PRO100 will also be connected to the patient in observation mode for data collection purposes only (not used for titration decisions).
Patients randomized to the intervention arm will receive supplemental oxygen via nasal cannula (recommended up to 6 lpm) or face mask (recommended up to 15 lpm) and will have supplemental oxygen titrated using an autonomous oxygen titration system for the first 72 hours after randomization, or hospital discharge (whichever sooner).
Device: Automated Titration (O2matic)
The patient will receive supplemental oxygen titrated using an autonomous oxygen titration device. The patient will be monitored and vital signs documented by the site's usual SpO2 assessments, but oxygen titration will occur automatically through the O2matic PRO100 device during the intervention period, unless there is a safety concern. The SpO2 range programmed into the PRO100 is 92-94%. The acceptable SpO2 range for the protocol is 90-96%. If a patient requires \>15lpm or other signs of advancing respiratory failure, they will be taken off the autonomous oxygen and transitioned to higher flow oxygen devices or mechanical ventilation per usual clinical care. If the patient is not receiving any supplemental oxygen per the autonomous titration, the clinical team may remove the oxygen delivery device from the patient, but the patient should remain connected to the PRO100 for the duration of the intervention period for data collection and to monitor for new supplemental oxygen needs.
Percentage of Time Spent Within the Targeted Normoxemia Range
The primary endpoint is percentage of time spent within the targeted normoxemia range, defined as an oxygen saturation (SpO2) of 90-96% (target 93%), as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomization, censored at hospital discharge, escalation to high flow nasal oxygen/mechanical ventilation, or death if prior to 72 hours.
Time frame: during first 72 hours after randomization, censored at hospital discharge, escalation to high flow nasal oxygen/mechanical ventilation, or death if prior to 72 hours.
Percentage of Time Spent in Hypoxemia (SpO2<88%)
Percentage of time spent in hypoxemia (SpO2 \<88%) during the first 72 hours after randomization.
Time frame: during first 72 hours after randomization
Percentage of Time Spent in Hyperoxemia (SpO2 >96%)
Percentage of time spent in hyperoxemia (SpO2 \>96%) during the first 72 hours after randomization.
Time frame: during first 72 hours after randomization
Amount of Supplemental Oxygen Administered
defined as total estimated oxygen volume during the first 72 hours after randomization.
Time frame: during first 72 hours after randomization
Time to Room Air
defined as the time from hospital presentation to the first episode of no supplemental oxygen (room air), censored at discharge or death.
Time frame: censored at day 28, discharge if before day 28, or death.
Adults (≥18 years old) hospitalized with acute respiratory illness, trauma, burns, or acute care surgery receiving 1 to 10 L of supplemental oxygen, and who could be randomized within 36 hours of hospitalization were recruited.
| Milestone | Intervention (Automated Titration) | Usual Care (Manual Titration) |
|---|---|---|
| Started | 152 | 148 |
| Completed | 152 | 148 |
| Not completed | 0 | 0 |
The primary endpoint is percentage of time spent within the targeted normoxemia range, defined as an oxygen saturation (SpO2) of 90-96% (target 93%), as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomization, censored at hospital discharge, escalation to high flow nasal oxygen/mechanical ventilation, or death if prior to 72 hours.
| Percentage of time spent in normoxemia | Intervention (Automated Titration) | Usual Care (Manual Titration) |
|---|---|---|
| Percentage of Time Spent Within the Targeted Normoxemia Range | 85 ± 1 | 63 ± 2 |
Percentage of time spent in hypoxemia (SpO2 \<88%) during the first 72 hours after randomization.
| Percentage of time spent in hypoxemia | Intervention (Automated Titration) | Usual Care (Manual Titration) |
|---|---|---|
| Hypoxemia (SpO2 <88%) | 2.0 ± 0.2 | 3.6 ± 0.4 |
| Borderline Hypoxemia (SpO2 88%-89%) | 3.4 ± 0.3 | 4.0 ± 0.4 |
Percentage of time spent in hyperoxemia (SpO2 \>96%) during the first 72 hours after randomization.
| Percentage of time spent in hyperoxemia | Intervention (Automated Titration) | Usual Care (Manual Titration) |
|---|---|---|
| Percentage of Time Spent in Hyperoxemia (SpO2 >96%) | 9 ± 1 | 29 ± 2 |
defined as total estimated oxygen volume during the first 72 hours after randomization.
| Thousands of L | Intervention (Automated Titration) | Usual Care (Manual Titration) |
|---|---|---|
| Amount of Supplemental Oxygen Administered | 2.31 (1.05 to 3.57) | 2.99 (2.30 to 4.27) |
defined as the time from hospital presentation to the first episode of no supplemental oxygen (room air), censored at discharge or death.
| Days | Intervention (Automated Titration) | Usual Care (Manual Titration) |
|---|---|---|
| Time to Room Air | 1.05 (0.45 to 2.91) | 1.15 (0.64 to 2.65) |
Collected over From randomization through day 28, death, or discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention (Automated Titration) | 0/152 (0%) | 0/152 (0%) | 4/152 (2.6%) |
| Usual Care (Manual Titration) | 0/148 (0%) | 0/148 (0%) | 1/148 (0.7%) |
| Event | Intervention (Automated Titration) | Usual Care (Manual Titration) |
|---|---|---|
| EpistaxisInjury, poisoning and procedural complications | 2/152 | 0/148 |
| Sinus Pain/DiscomfortInjury, poisoning and procedural complications | 2/152 | 0/148 |
| Skin VesicleSkin and subcutaneous tissue disorders | 0/152 | 1/148 |
| Age, Customized(Years) | Intervention (Automated Titration) | Usual Care (Manual Titration) | Total |
|---|---|---|---|
| Age, Median (IQR), y | 68 (59 to 77) | 64 (53 to 72) | 66 (55 to 75) |
| Sex: Female, Male(Participants) | Intervention (Automated Titration) | Usual Care (Manual Titration) | Total |
|---|---|---|---|
| Female | 87 | 75 | 162 |
| Male | 65 | 73 | 138 |
| Race/Ethnicity, Customized(Participants) | Intervention (Automated Titration) | Usual Care (Manual Titration) | Total |
|---|---|---|---|
| Black, non-Hispanic | 26 | 28 | 54 |
| Hispanic | 9 | 10 | 19 |
| White, non-Hispanic | 113 | 105 | 218 |
| Other | 4 | 5 | 9 |
| Monk Skin Tone (MST) Scale(Participants) | Intervention (Automated Titration) | Usual Care (Manual Titration) | Total |
|---|---|---|---|
| Light : | 38 | 29 | 67 |
| Medium : | 83 | 85 | 168 |
| Dark : | 31 | 34 | 65 |
| Primary reason for hospital admission(Participants) | Intervention (Automated Titration) | Usual Care (Manual Titration) | Total |
|---|---|---|---|
| Acute respiratory illness : | 106 | 102 | 208 |
| Traumatic injury/burn/acute care surgery : | 46 | 46 | 92 |
| Admitted to an ICU at time of enrollment(Participants) | Intervention (Automated Titration) | Usual Care (Manual Titration) | Total |
|---|---|---|---|
| Count of participants | 38 | 35 | 73 |
| Oxygen flow rate at randomization, L/min(Participants) | Intervention (Automated Titration) | Usual Care (Manual Titration) | Total |
|---|---|---|---|
| 1.0-2.9 L/min : | 77 | 68 | 145 |
| 3.0-4.9 L/min : | 57 | 53 | 110 |
| 5.0-10 L/min : | 18 | 27 | 45 |
| Chronic pulmonary disease(Participants) | Intervention (Automated Titration) | Usual Care (Manual Titration) | Total |
|---|---|---|---|
| Count of participants | 65 | 63 | 128 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Douin DJ, Rice JD, Xiao M, Beaty LE, Guo CJ, Withers C, Sullivan A, Anderson EL, Cheng AC, Banasiewicz MK, Semler MW, Lloyd BD, Maiga AW, Gibbs KW, Stettler GR…PubMed 42546017 ↗
Douin DJ, Rice JD, Xiao M, Beaty LE, Guo CJ, Withers C, Sullivan A, Anderson EL, Cheng AC, Banasiewicz MK, Semler MW, Lloyd BD, Maiga AW, Gibbs KW, Stettler GR…PubMed 42546017 ↗
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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