A Phase 3 interventional study of Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg) in Critical Illness, Wounds and Injury and Disease Attributes, sponsored by University of Colorado, Denver. Active, not recruiting at 6 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by University of Colorado, Denver · Phase 3, Interventional, and Treatment
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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This study's planned enrollment of 2,000 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
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).
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).
Other: Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)
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).
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 \[best outcome\])
Time frame: up to 28 days
Hospital-Free Days to day 90 (HFD90)
Number of days alive and outside the hospital (0 days \[worst outcome\] to 90 days \[best outcome\])
Time frame: 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
Time frame: 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
Time frame: up to 90 days
Ventilator Free Days (VFD) to day 28
Ventilator Free days = Days off ventilator (0 VFD \[worst outcome\] to 28 VFD \[best outcome\])
Time frame: up to 28 days
Time to Room air
Duration of supplemental oxygen (FiO2 = 0.21 or room air)
Time frame: 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)
Time frame: up to 90 days
Discharge Disposition
Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility)
Time frame: up to 90 days
Amount of Supplemental Oxygen Administered
Total estimated oxygen volume while in the burn until after hospital arrival
Time frame: 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
Time frame: 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 \[excludes time in the operating room\]
Time frame: 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
Time frame: up to 90 days
Duration of Time Receiving No Supplemental Oxygen
FiO2 0.21 or room air while in the burn unit
Time frame: up to 90 days
Incidence of Hypoxemic Event (SpO2<88%)
SpO2 saturation below 88% while in the burn unit
Time frame: up to 90 days
Duration of Hypoxemic Events (SpO2<88%)
SpO2 saturation below 88% while in the burn unit
Time frame: up to 90 days
Incidence of Hyperoxemic Event (SpO2>96%)
SpO2 saturation above 96% while in the burn unit
Time frame: up to 90 days
Duration of Hyperoxemic Event (SpO2>96%)
SpO2 saturation above 96% while in the burn unit
Time frame: up to 90 days
Plan to share: No
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver