Clinical trial NCT04534959: Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients
Official title: Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Critical Illness
Wounds and Injury
Disease Attributes
Pathologic Processes
Keywords: hypoxia
hyperoxia
trauma
burn
critical illness
supplemental oxygen
oxygenation
SpO2
PaO2
FiO2
normoxia
hypoxemia
normoxemia
hyperoxemia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-09-01
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Supplemental Oxygen Free Days (SOFD)
timeFrame: up to 28 days
Secondary outcomes:
measure: Hospital-Free Days to day 90 (HFD90)
timeFrame: up to 90 days
measure: In-hospital Mortality to day 90
timeFrame: up to 90 days
measure: Time to Mortality to day 90
timeFrame: up to 90 days
measure: Ventilator Free Day (VFD) to day 28
timeFrame: up to 28 days
measure: Time to Room Air
timeFrame: up to 90 days
measure: Glasgow Outcome Score (GOS)
timeFrame: up to 90 days
measure: Discharge Disposition
timeFrame: up to 90 days
measure: Amount of Supplemental Oxygen Administered
timeFrame: up to 90 days
measure: Duration of Time on Normoxemia Protocol Target
timeFrame: up to 90 days
measure: Proportion of Participants Receiving High Levels of Supplemental Oxygen
timeFrame: up to 90 days
measure: Duration of Time receiving High Levels of Supplemental Oxygen
timeFrame: up to 90 days
measure: Duration of Time Receiving No Supplemental Oxygen
timeFrame: up to 90 days
measure: Incidence of Hypoxemic Event (SpO2<88%)
timeFrame: up to 28 days
measure: Duration of Hypoxemic Events (SpO2<88%)
timeFrame: up to 90 days
measure: incidence of Hyperoxemic Event (SpO2>96%)
timeFrame: up to 90 days
measure: Duration of Hyperoxemic Event (SpO2>96%)
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham Medical Center
state: Alabama
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: University of Colorado, Denver
name: Adit Ginde, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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