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

Primary Purpose

Critical Illness, Wounds and Injury, Disease Attributes

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring hypoxia, hyperoxia, burn, critical illness, supplemental oxygen, oxygenation, SpO2, PaO2, FiO2, normoxia, hypoxemia, hyperoxemia, normoxemia

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama-Birmingham Medical Center
  • University of Colorado
  • University of Cincinnati Medical Center
  • University of Pittsburgh Medical Center
  • Vanderbilt University Medical Center
  • Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Pre-Implementation

Post-Implementation Targeting Normoxemia in Burn ICU

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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])

Secondary Outcome Measures

Hospital-Free Days to day 90 (HFD90)
Number of days alive and outside the hospital (0 days [worst outcome] to 90 days [best outcome])
In-hospital Mortality to day 90
Dichotomous vital status (survived or died) at hospital discharge or day 90, whichever is first
Time to Mortality to day 90
Vital status and date of death censored at hospital discharge or day 90, whichever is first
Ventilator Free Days (VFD) to day 28
Ventilator Free days = Days off ventilator (0 VFD [worst outcome] to 28 VFD [best outcome])
Time to Room air
Duration of supplemental oxygen (FiO2 = 0.21 or room air)
Time to Burn Wound Healing
Wound closure of >90% of the original burn or time to grafting (for non-full thickness wounds)
Discharge Disposition
Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility)
Amount of Supplemental Oxygen Administered
Total estimated oxygen volume while in the burn until after hospital arrival
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
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]
Duration of Time Receiving High Levels of Supplemental Oxygen
FiO2>0.40 or >4 liters per minute while in the burn unit
Duration of Time Receiving No Supplemental Oxygen
FiO2 0.21 or room air while in the burn unit
Incidence of Hypoxemic Event (SpO2<88%)
SpO2 saturation below 88% while in the burn unit
Duration of Hypoxemic Events (SpO2<88%)
SpO2 saturation below 88% while in the burn unit
Incidence of Hyperoxemic Event (SpO2>96%)
SpO2 saturation above 96% while in the burn unit
Duration of Hyperoxemic Event (SpO2>96%)
SpO2 saturation above 96% while in the burn unit

Full Information

First Posted
August 25, 2020
Last Updated
January 4, 2023
Sponsor
University of Colorado, Denver
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04534972
Brief Title
Strategy to Avoid Excessive Oxygen in Major Burn Patients
Acronym
SAVE-O2
Official Title
Strategy to Avoid Excessive Oxygen in Major Burn Patients (SAVE-O2)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-Implementation
Arm Type
No Intervention
Arm Description
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).
Arm Title
Post-Implementation Targeting Normoxemia in Burn ICU
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Supplemental Oxygen Free Days (SOFD)
Description
Number of days alive and not on supplemental oxygen during the index hospitalization (0 days [worst outcome] to 28 days [best outcome])
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Hospital-Free Days to day 90 (HFD90)
Description
Number of days alive and outside the hospital (0 days [worst outcome] to 90 days [best outcome])
Time Frame
up to 90 days
Title
In-hospital Mortality to day 90
Description
Dichotomous vital status (survived or died) at hospital discharge or day 90, whichever is first
Time Frame
up to 90 days
Title
Time to Mortality to day 90
Description
Vital status and date of death censored at hospital discharge or day 90, whichever is first
Time Frame
up to 90 days
Title
Ventilator Free Days (VFD) to day 28
Description
Ventilator Free days = Days off ventilator (0 VFD [worst outcome] to 28 VFD [best outcome])
Time Frame
up to 28 days
Title
Time to Room air
Description
Duration of supplemental oxygen (FiO2 = 0.21 or room air)
Time Frame
up to 90 days
Title
Time to Burn Wound Healing
Description
Wound closure of >90% of the original burn or time to grafting (for non-full thickness wounds)
Time Frame
up to 90 days
Title
Discharge Disposition
Description
Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility)
Time Frame
up to 90 days
Title
Amount of Supplemental Oxygen Administered
Description
Total estimated oxygen volume while in the burn until after hospital arrival
Time Frame
up to 90 days
Title
Duration of Time on Normoxemia Protocol Target
Description
Defined as SpO2 90-96% or receiving no supplemental oxygen (FiO2 0.21 or room air) while in the burn unit
Time Frame
up to 90 days
Title
Proportion of Participants Receiving High Levels of Supplemental Oxygen
Description
FiO2>0.40 or >4 liters per minute for >2 hours while in the burn unit [excludes time in the operating room]
Time Frame
up to 90 days
Title
Duration of Time Receiving High Levels of Supplemental Oxygen
Description
FiO2>0.40 or >4 liters per minute while in the burn unit
Time Frame
up to 90 days
Title
Duration of Time Receiving No Supplemental Oxygen
Description
FiO2 0.21 or room air while in the burn unit
Time Frame
up to 90 days
Title
Incidence of Hypoxemic Event (SpO2<88%)
Description
SpO2 saturation below 88% while in the burn unit
Time Frame
up to 90 days
Title
Duration of Hypoxemic Events (SpO2<88%)
Description
SpO2 saturation below 88% while in the burn unit
Time Frame
up to 90 days
Title
Incidence of Hyperoxemic Event (SpO2>96%)
Description
SpO2 saturation above 96% while in the burn unit
Time Frame
up to 90 days
Title
Duration of Hyperoxemic Event (SpO2>96%)
Description
SpO2 saturation above 96% while in the burn unit
Time Frame
up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adit Ginde, MD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama-Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Army Institute of Surgical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Strategy to Avoid Excessive Oxygen in Major Burn Patients

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