Strategy to Avoid Excessive Oxygen in Major Burn Patients

Phase 3

Active, not recruiting

• Conditions: Disease Attributes; Pathologic Processes; Wounds and Injury; Critical Illness
• Interventions: Other: Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)

• Registration Number: NCT04534972
• 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 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

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-01
• Study Start: 2021-04-15
• Primary Completion: 2022-11-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Study Completion: 2025-02-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

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Exclusion Criteria

• Age <18 years
• Prisoners
• Known pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post-Implementation Targeting Normoxemia in Burn ICU	Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)	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).

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
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
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 burn unit \[excludes time in the operating room\]
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 \[best outcome\])
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
Ventilator Free Days (VFD) to day 28	up to 28 days	Ventilator Free days = Days off ventilator (0 VFD \[worst outcome\] to 28 VFD \[best outcome\])
Time to Burn Wound Healing	up to 90 days	Wound closure of \>90% of the original burn or time to grafting (for non-full thickness wounds)
Time to Room air	up to 90 days	Duration of supplemental oxygen (FiO2 = 0.21 or room air)
Incidence of Hypoxemic Event (SpO2<88%)	up to 90 days	SpO2 saturation below 88% while in the burn unit
Duration of Hypoxemic Events (SpO2<88%)	up to 90 days	SpO2 saturation below 88% while in the burn unit
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 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 burn unit
Duration of Time Receiving No Supplemental Oxygen	up to 90 days	FiO2 0.21 or room air while in the burn unit
Duration of Hyperoxemic Event (SpO2>96%)	up to 90 days	SpO2 saturation above 96% while in the burn unit
Amount of Supplemental Oxygen Administered	up to 90 days	Total estimated oxygen volume while in the burn until after hospital arrival
Duration of Time Receiving High Levels of Supplemental Oxygen	up to 90 days	FiO2\>0.40 or \>4 liters per minute while in the burn unit
Incidence of Hyperoxemic Event (SpO2>96%)	up to 90 days	SpO2 saturation above 96% while in the burn unit

Trial Locations

Locations (6)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Army Institute of Surgical Research; 🇺🇸 San Antonio, Texas, United States

University of Alabama-Birmingham Medical Center; 🇺🇸 Birmingham, Alabama, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States