Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients
- Conditions
- Disease AttributesCritical IllnessPathologic ProcessesWounds and Injury
- Interventions
- Other: Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)
- Registration Number
- NCT04534959
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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.
- Detailed Description
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:
1. Improve the proportion of time spent within target normoxemia thresholds (oxygen saturation \[SpO2\] 90-96% and/or arterial oxygen \[PaO2\] 60-100 mmHg \[when applicable\]
2. Limit use of excessive supplemental oxygen
3. Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 6000
- Acutely injured patients who meet the criteria for entry into the state or national trauma registry
- Admission to surgical/trauma ICU within 24 hours of hospital arrival
- Age <18 years
- Prisoners
- Known pregnancy
- Transferred patients not admitted through the emergency department
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Post-Implementation Targeting Normoxemia in Trauma ICU Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg) 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).
- Primary Outcome Measures
Name Time Method Supplemental Oxygen Free Days (SOFD) up to 28 days Number of days alive and not on supplemental oxygen during the index hospitalization (0 days \[worst outcome\] to 28 days \[best outcome\])
- Secondary Outcome Measures
Name Time Method Ventilator Free Day (VFD) to day 28 up to 28 days Ventilator Free Days = Days off ventilator (0 VFD \[worst outcome\] to 28 VFD \[best outcome\])
Hospital-Free Days to day 90 (HFD90) up to 90 days Number of days alive and outside the hospital (0 days \[worst outcome\] to 90 days \[best outcome\])
Amount of Supplemental Oxygen Administered up to 90 days Total estimated oxygen volume while in the ICU after hospital arrival
In-hospital Mortality to day 90 up to 90 days Dichotomous vital status (survived or died) at hospital discharge or day 90, whichever is first
Time to Mortality to day 90 up to 90 days Vital status and date of death censored at hospital discharge or day 90, whichever is first
Duration of Time receiving High Levels of Supplemental Oxygen up to 90 days FiO2\>0.40 or \>4 liters per minute while in the ICU
Glasgow Outcome Score (GOS) up to 90 days Patient will be assessed at hospital discharge with one of the following five categories: Death, Persistent Vegetative State, Severe Disability, Moderate Disability, Low Disability
Time to Room Air up to 90 days Duration of supplemental oxygen (FiO2 = 0.21 or room air)
Discharge Disposition up to 90 days Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility)
Duration of Hyperoxemic Event (SpO2>96%) up to 90 days SpO2 saturation above 96% while in the ICU
Duration of Time on Normoxemia Protocol Target up to 90 days Defined as SpO2 90-96% or receiving no supplemental oxygen (FiO2 0.21 or room air) while in the ICU
Proportion of Participants Receiving High Levels of Supplemental Oxygen up to 90 days FiO2\>0.40 or \>4 liters per minute for \>2 hours while in the ICU \[excludes time in the operating room\]
Incidence of Hypoxemic Event (SpO2<88%) up to 28 days SpO2 saturation below 88% while in the ICU
Duration of Hypoxemic Events (SpO2<88%) up to 90 days SpO2 saturation below 88% while in the ICU
incidence of Hyperoxemic Event (SpO2>96%) up to 90 days SpO2 saturation above 96% while in the ICU
Duration of Time Receiving No Supplemental Oxygen up to 90 days FiO2 0.21 or room air while in the ICU
Trial Locations
- Locations (8)
University of Alabama-Birmingham Medical Center
🇺🇸Birmingham, Alabama, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Denver Health
🇺🇸Denver, Colorado, United States