Strategy to Avoid Excessive Oxygen in Major Burn Patients

Study Overview
=================
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: 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]) Limiting use of excessive supplemental oxygen Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects

Official Title
-----------------
Strategy to Avoid Excessive Oxygen in Major Burn Patients (SAVE-O2)

Conditions
-----------------
Critical Illness, Wounds and Injury, Disease Attributes, Pathologic Processes

Intervention / Treatment
-----------------
* Other: Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-Implementation<br>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). | |
| Active Comparator: Post-Implementation Targeting Normoxemia in Burn ICU<br>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)<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Ventilator Free Days (VFD) to day 28 | Ventilator Free days = Days off ventilator (0 VFD [worst outcome] to 28 VFD [best outcome]) | up to 28 days | 
| Time to Room air | Duration of supplemental oxygen (FiO2 = 0.21 or room air) | 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) | up to 90 days | 
| Discharge Disposition | Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility) | up to 90 days | 
| Amount of Supplemental Oxygen Administered | Total estimated oxygen volume while in the burn until after hospital arrival | 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 | 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] | 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 | up to 90 days | 
| Duration of Time Receiving No Supplemental Oxygen | FiO2 0.21 or room air while in the burn unit | up to 90 days | 
| Incidence of Hypoxemic Event (SpO2<88%) | SpO2 saturation below 88% while in the burn unit | up to 90 days | 
| Duration of Hypoxemic Events (SpO2<88%) | SpO2 saturation below 88% while in the burn unit | up to 90 days | 
| Incidence of Hyperoxemic Event (SpO2>96%) | SpO2 saturation above 96% while in the burn unit | up to 90 days | 
| Duration of Hyperoxemic Event (SpO2>96%) | SpO2 saturation above 96% while in the burn unit | up to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoxia, hyperoxia, burn, critical illness, supplemental oxygen, oxygenation, SpO2, PaO2, FiO2, normoxia, hypoxemia, hyperoxemia, normoxemia