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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.
Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxemia. Although routine, the practice of excessive over-oxygenation may be harmful. An expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (SpO2) range of 90-96%, an arterial oxygen (PaO2) range of 60-100 mmHg (when applicable), and a fraction of inspired oxygen (FiO2) of 21% for mechanically ventilated patients or room air for nonmechanically ventilated patients.
Specific Aim: The purpose of this study is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in critically injured patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.
Hypotheses: Clinical efforts to through a multimodal educational intervention will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Implementation | No Intervention | The control (pre-implementation) group will be trauma patients admitted to the surgical/trauma ICU during the site's control period of the stepped-wedge implementation process (up to 22 months). | |
| Post-Implementation Targeting Normoxemia in Trauma ICU | Experimental | The intervention (post-implementation) group will be patients admitted to the surgical/trauma ICU during the targeted normoxemia intervention period of the stepped-wedge implementation process (up to 25 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg) | Other | Post-implementation of targeted normoxemia through oxygen titration for individual patients. Interventions for treatment of hypoxemia will follow usual local practice. Interventions for treatment of hyperoxemia (SpO2 >96% or PaO2 >100 mmHg) will involve down titration of FiO2 (or supplemental oxygen for non-mechanically ventilated patients) within a time frame based on local site preferences-typically in increments of no greater than 0.10 until goal oxygenation in the normoxemia range is achieved (including room air [no supplemental oxygen] for non-mechanically ventilated patients). |
| Measure | Description | Time Frame |
|---|---|---|
| Supplemental Oxygen Free Days (SOFD) | Number of days alive and not on supplemental oxygen during the index hospitalization (0 days [worst outcome] to 28 days [best outcome]) | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital-Free Days to day 90 (HFD90) | Number of days alive and outside the hospital (0 days [worst outcome] to 90 days [best outcome]) | up to 90 days |
| In-hospital Mortality to day 90 | Dichotomous vital status (survived or died) at hospital discharge or day 90, whichever is first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adit Ginde, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama-Birmingham Medical Center | Birmingham | Alabama | 35294 | United States | ||
| Denver Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18216624 | Background | Leverve XM. To cope with oxygen: a long and still tumultuous story for life. Crit Care Med. 2008 Feb;36(2):637-8. doi: 10.1097/CCM.0B013E31816296AD. No abstract available. | |
| 25532567 | Background | Damiani E, Adrario E, Girardis M, Romano R, Pelaia P, Singer M, Donati A. Arterial hyperoxia and mortality in critically ill patients: a systematic review and meta-analysis. Crit Care. 2014 Dec 23;18(6):711. doi: 10.1186/s13054-014-0711-x. |
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|
| up to 90 days |
| Time to Mortality to day 90 | Vital status and date of death censored at hospital discharge or day 90, whichever is first | up to 90 days |
| Ventilator Free Day (VFD) to day 28 | Ventilator Free Days = Days off ventilator (0 VFD [worst outcome] to 28 VFD [best outcome]) | up to 28 days |
| Time to Room Air | Duration of supplemental oxygen (FiO2 = 0.21 or room air) | up to 90 days |
| Glasgow Outcome Score (GOS) | Patient will be assessed at hospital discharge with one of the following five categories: Death, Persistent Vegetative State, Severe Disability, Moderate Disability, Low Disability | up to 90 days |
| Discharge Disposition | Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility) | up to 90 days |
| Amount of Supplemental Oxygen Administered | Total estimated oxygen volume while in the ICU after hospital arrival | up to 90 days |
| Duration of Time on Normoxemia Protocol Target | Defined as SpO2 90-96% or receiving no supplemental oxygen (FiO2 0.21 or room air) while in the ICU | up to 90 days |
| Proportion of Participants Receiving High Levels of Supplemental Oxygen | FiO2>0.40 or >4 liters per minute for >2 hours while in the ICU [excludes time in the operating room] | up to 90 days |
| Duration of Time receiving High Levels of Supplemental Oxygen | FiO2>0.40 or >4 liters per minute while in the ICU | up to 90 days |
| Duration of Time Receiving No Supplemental Oxygen | FiO2 0.21 or room air while in the ICU | up to 90 days |
| Incidence of Hypoxemic Event (SpO2<88%) | SpO2 saturation below 88% while in the ICU | up to 28 days |
| Duration of Hypoxemic Events (SpO2<88%) | SpO2 saturation below 88% while in the ICU | up to 90 days |
| incidence of Hyperoxemic Event (SpO2>96%) | SpO2 saturation above 96% while in the ICU | up to 90 days |
| Duration of Hyperoxemic Event (SpO2>96%) | SpO2 saturation above 96% while in the ICU | up to 90 days |
| Denver |
| Colorado |
| 80204 |
| United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| 40163121 | Derived | Douin DJ, Rice JD, Anderson EL, Jackson CL, Cheng AC, Xiao M, Cwik J, Beaty LE, Wild JL, Daya MR, Doshi PB, Eastham SC, Goodman MD, Gunn SR, Haukoos JS, Hudson JA, Jansen JO, McMullan JT, Rizzo JA, Schreiber MA, Self WH, Semler MW, Steinwand A, Werner N, Bebarta VS, Schauer SG, Ginde AA; Strategy to Avoid Excessive Oxygen (SAVE-O2) Investigators. Targeted Normoxemia and Supplemental Oxygen-Free Days in Critically Injured Adults: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e252093. doi: 10.1001/jamanetworkopen.2025.2093. |
| 34749762 | Derived | Dylla L, Douin DJ, Anderson EL, Rice JD, Jackson CL, Bebarta VS, Lindsell CJ, Cheng AC, Schauer SG, Ginde AA. A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial. Trials. 2021 Nov 8;22(1):784. doi: 10.1186/s13063-021-05688-6. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D000860 | Hypoxia |
| D018496 | Hyperoxia |
| D002056 | Burns |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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