Clinical trial NCT04534972: Strategy to Avoid Excessive Oxygen in Major Burn Patients
Official title: Strategy to Avoid Excessive Oxygen in Major Burn 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
burn
critical illness
supplemental oxygen
oxygenation
SpO2
PaO2
FiO2
normoxia
hypoxemia
hyperoxemia
normoxemia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-09-01
Enrollment: 2000
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 major burn 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 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:

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. Limiting use of excessive supplemental oxygen
3. Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects

Eligibility criteria: Inclusion Criteria:

* Patients with acute thermal burn injury who meet the criteria for entry into the state or national burn data repository
* Admission to burn unit within 24 hours of burn injury

Exclusion Criteria:

* Age \<18 years
* Prisoners
* Known pregnancy

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 Days (VFD) to day 28
timeFrame: up to 28 days
measure: Time to Room air
timeFrame: up to 90 days
measure: Time to Burn Wound Healing
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 90 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: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
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: San Antonio
country: United States
facility: Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: University of Colorado, Denver
name: Adit Ginde, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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