Critical Illness Clinical Trial
— SAVE-O2Official title:
Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2)
Verified date | April 2024 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 6000 |
Est. completion date | February 15, 2025 |
Est. primary completion date | November 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Age <18 years - Prisoners - Known pregnancy - Transferred patients not admitted through the emergency department |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama-Birmingham Medical Center | Birmingham | Alabama |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Denver Health | Denver | Colorado |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Oregon Health and Sciences University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | United States Department of Defense |
United States,
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* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | In-hospital Mortality to day 90 | Dichotomous vital status (survived or died) at hospital discharge or day 90, whichever is first | up to 90 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Time to Room Air | Duration of supplemental oxygen (FiO2 = 0.21 or room air) | up to 90 days | |
Secondary | 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 | |
Secondary | Discharge Disposition | Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility) | up to 90 days | |
Secondary | Amount of Supplemental Oxygen Administered | Total estimated oxygen volume while in the ICU after hospital arrival | up to 90 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Duration of Time Receiving No Supplemental Oxygen | FiO2 0.21 or room air while in the ICU | up to 90 days | |
Secondary | Incidence of Hypoxemic Event (SpO2<88%) | SpO2 saturation below 88% while in the ICU | up to 28 days | |
Secondary | Duration of Hypoxemic Events (SpO2<88%) | SpO2 saturation below 88% while in the ICU | up to 90 days | |
Secondary | incidence of Hyperoxemic Event (SpO2>96%) | SpO2 saturation above 96% while in the ICU | up to 90 days | |
Secondary | Duration of Hyperoxemic Event (SpO2>96%) | SpO2 saturation above 96% while in the ICU | up to 90 days |
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