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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 major burn 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 major burn 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 burn patients admitted to the burn unit in ICU during the site's control period of the stepped-wedge implementation process (up to 22 months). | |
| Post-Implementation Targeting Normoxemia in Burn ICU | Active Comparator | The intervention (post-implementation) group will be patients admitted to the burn unit in ICU during the targeting normoxemia intervention period of the stepped-wedge design implementation process (up to 19 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. Intervention 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 | ||
| University of Colorado |
| 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 Days (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 |
| Time to Burn Wound Healing | Wound closure of >90% of the original burn or time to grafting (for non-full thickness wounds) | 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 burn until 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 burn unit | 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 burn unit [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 burn unit | up to 90 days |
| Duration of Time Receiving No Supplemental Oxygen | FiO2 0.21 or room air while in the burn unit | up to 90 days |
| Incidence of Hypoxemic Event (SpO2<88%) | SpO2 saturation below 88% while in the burn unit | up to 90 days |
| Duration of Hypoxemic Events (SpO2<88%) | SpO2 saturation below 88% while in the burn unit | up to 90 days |
| Incidence of Hyperoxemic Event (SpO2>96%) | SpO2 saturation above 96% while in the burn unit | up to 90 days |
| Duration of Hyperoxemic Event (SpO2>96%) | SpO2 saturation above 96% while in the burn unit | up to 90 days |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Army Institute of Surgical Research | San Antonio | Texas | 78234 | United States |
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| 40604863 | Derived | Douin DJ, Rice JD, Xiao M, Jackson CL, Anderson EL, Cheng AC, Cwik J, Beaty LE, Wild JL, Beyene RT, Britton GW, Corcos AC, Dale EL, Hwang J, Jansen JO, Self WH, Slater JC, Steinwand A, Wiktor AJ, Ziembicki J, Schauer SG, Bebarta VS, Cancio L, Ginde AA; Strategy to Avoid Excessive Oxygen (SAVE-O2) Investigators. Effect of targeting normoxemia on supplemental oxygen-free days for adults with acute thermal burns: A stepped wedge cluster randomized clinical trial. J Trauma Acute Care Surg. 2025 Oct 1;99(4):619-627. doi: 10.1097/TA.0000000000004712. Epub 2025 Jul 3. |
| 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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